ESBD_File_347573_HHS0014056 Exhibit J Criteria Response Sheet .pdf

HHS0014056

Exhibit J Criteria Response Sheet

Company Name:

Respondent Name: Print name, sign, and date

Respondent shall enter a response for each listed criteria. Please do not leave any blanks.

7.1 SCOPE OF WORK (SOW) TO BE PERFORMED

7.1.1 Multi-User Electric Pump

Criteria Response

1. Must provide new pumps. Contractor may optionally provide per unit pricing for refurbished pumps, if available. HHSC may purchase refurbished pumps at its discretion.

2. Be pre-assembled and include listed parts and accessories within pump packaging.

3. Operate on a 110-volt household current and be UL listed

4. Have double pumping capacity, which is simultaneous, not alternating.

5. Be easy to clean, using common household detergents.

6. Be designed for repeated use by more than one (1) woman.

7. Have an adjustable suction pressure between 30 mm Hg and 250 mm Hg at the breast shield during use; a suction range just at the low or high end of the range is not acceptable.

8. Automatically cycle.

9. Have adjustable or variable cycling with the ability to cycle up to a range of sixty (60) to seventy-two (72) times per minute.

10. Be designed to prevent breastmilk from entering the pump motor housing unit or come in contact with any internal pump parts to avoid potential contamination of breastmilk.

11. Be designed to work with sterile milk collection kits and additional sized breast flanges described in specifications.

12. Comply with all the Food and Drug Administration (FDA) requirements as a multi-user electric pump. Contractor shall provide HHSC proof of marketing clearance. Note: This will be documented and tracked using controlled correspondence, per Section 7.9 Controlled Correspondence.

13. Be effective at establishing and maintaining a mother’s milk supply for majority of users.

14. Be efficient enough that a pumping session can be completed in 20-30 minutes.

15. Include a soft carrying case and an optional hard carrying case that shall:

• Be made of durable, washable material easily cleaned and disinfected.

• Be designed for repeated use by more than one (1) woman.

• Include a shoulder strap, preferably adjustable.

• Include an insulated section or separate insulated case and

2 to 4 cold packs to accommodate transportation of breastmilk in manufacturers’ milk collection containers.

• Soft carrying cases shall weigh no more than approximately ten (10) pounds with the pump inside (weight to exclude cold packs or separate insulated carrying cases and cold packs).

• Hard carrying cases shall weigh no more than approximately thirteen (13) pounds with the pump inside

(weight to exclude cold packs or separate insulated carrying cases and cold packs).

16. Have battery adaptability and include a vehicle adapter or USB charging cord, which can be plugged in to and used in any vehicle.

7.1.2 Sterile Milk Collection Kit for use with Multi-User Electric Pump:

Criteria Response

1. Be specifically designed and manufactured to work with multi-user electric breast pump provided by the Contractor.

2. Be sterilized prior to packaging, fully or partially assembled, and ready for immediate use upon delivery. Parts and accessories shall be packaged together within collection kit packaging.

3. Be made of materials that maintain integrity and functionality, allowing for repeated boiling and dishwasher cleaning.

4. Be BPA and bis(2-ethylhexyl) phthalate (DEHP)-free.

5. Include a minimum of two (2) pairs of different standard sized breast flanges, to accommodate different sized breasts and nipples. Flanges should meet criteria and safety standards for use. Respondents shall list size of flanges in millimeters on bid and Pricing Sheet, see Exhibit H Cost Proposal

6. Include at least two (2) reusable milk collection containers with spill-proof caps:

• Are easy to remove with minimal spillage.

• Hold a minimum of four (4) ounces and no more than six

(6) ounces.

7. Include tubing material that is comparable to standard tubing used for breast pumps, able to endure multiple uses and is specific to the multi-user electric pump.

8. Include at least one (1) extra membrane and/or valve.

9. Include all parts to easily convert to a manual pump.

10. Not contain accessories that are not compatible with multi-user electric pump or manual pump unless specified in this solicitation.

7.1.3 Single-User Electric Pump with Milk Collection Accessories:

1. Include a milk collection kit that is fully or at least partially assembled.

2. Is made of materials that maintain integrity and functionality, allowing for repeated boiling and dishwashing cleaning.

3. Be (BPA) and bis(2-ethylhexyl) phthalate (DEHP)-free.

4. Include a minimum of two (2) pairs of different standard sized breast flanges, to accommodate different sized breasts and nipples. Flanges should meet criteria and safety standards for use. Respondents shall list size of flanges in millimeters on bid and Pricing Sheet, see Exhibit H Cost Proposal.

5. Includes at least two (2) reusable milk collection containers with spill-proof standard size caps:

• Are easy to remove with minimal spillage.

• Include tubing material that meets industry standard and is specific to the single-user electric pump.

• Includes at least one (1) extra membrane and/or valve.

• Contain all parts to easily convert to a manual pump.

6. Be UL or equivalent listed and use a 110-volt electrical outlet.

7. Have double pumping capacity, which is simultaneous, not alternating.

8. Be easy to clean, using common household detergents.

9. Include carrying case. Carrying case shall:

• Be made of durable, washable material.

• Include a shoulder strap, preferably adjustable.

• Include an insulated section or separate insulated case.

• Include 2 to 4 cold packs to accommodate transportation of breastmilk in manufacturers’ milk collection containers.

10. Have an adjustable suction pressure between 30 mm Hg and 250 mm Hg at the breast shield during use; a suction range just at the low or high end of the range is not acceptable.

11. Automatically cycle.

12. Have adjustable or variable cycling with the ability to cycle up to a range of sixty (60) to seventy-two (72) times per minute.

13. Have battery adaptability and vehicle adapter, which can be plugged into any vehicle.

14. Be designed to prevent breastmilk from entering the pump motor housing unit or come in contact with any internal pump parts to avoid potential contamination of breastmilk.

15. Comply with all Food and Drug Administration (FDA) requirements as a single-user electric pump. Contractor shall provide proof of marketing clearance. Note: This will be

16. Be effective at establishing and maintaining a mother’s milk supply for most users.

17. Be efficient enough that a pumping session can be completed

18. Parts and accessories listed above shall be packaged together within pump packaging.

7.1.4 Manual Pump with Milk Collection Accessories:

1. Be designed to create suction which is independent of the collection bottle.

2. Be easy to clean, using common household detergents.

3. Have the ability to reach a minimum of 220 mm Hg of pressure at the breast flange.

4. Have safety precautions to prevent suction from getting too high, > 250 mm Hg.

5. Have a mechanism that allows for variable pressures to be adjusted by the end user.

6. Have the ability to reach a maximum pressure in a minimum of one (1) second.

7. Be (BPA) and bis(2-ethylhexyl) phthalate (DEHP)-free.

8. Include a minimum of two (2) different sized breast flanges, which include one (1) standard size, to accommodate different sized breasts and nipples. Flanges should meet criteria and safety standards for use. Respondents shall list size of flanges in millimeters on bid and Pricing Sheet, see Exhibit H Cost Proposal.

9. Include at least one (1) extra membrane and/or valve.

10. Have the ability to adapt to two (2) or more additional sized breast flanges, which are comfortable for most users, to accommodate different size breasts and nipples.

11. Have the ability to pump the breast with a smooth action.

12. Be easy to disassemble, clean and reassemble.

13. Be made of materials that maintain integrity and functionality, allowing for repeated boiling and dishwasher cleaning.

14. Be effective in extracting milk for the majority of users.

15. Be efficient enough that a pumping session can be completed

16. Be packaged pre-assembled with all parts necessary for pumping with a minimum of one hand and be intended for a single user. Be lightweight and portable requiring no electricity.

7.1.5 Additional Sized Breast Flanges:

1. Be specifically designed to work with the products described in the sterile milk collection kits, single-user electric pump, and manual pump specifications.

2. Be available in two (2) or more additional flange sizes different from those included in the sterile milk collection kits, single-user electric pump, and manual pump specifications.

3. Respondents shall list size of flanges in millimeters on bid and Pricing Sheet, see Exhibit H Cost Proposal.

4. Be (BPA) and bis(2-ethylhexyl) phthalate (DEHP)-free.

7.1.6 Printed Materials:

1. Be included with all awarded products.

2. All pumps should include assembly of pump, use, cleaning instructions and a link to online videos, unless otherwise specified within this solicitation.

3. Include pictures or diagrams that support the written instructions.

4. Be written at the 4th grade (or lower) literacy level.

5. Be in both English and Spanish.

6. Be free of additional material advertisement of infant feeding supplements and devices unrelated to contracted products unless authorized by WIC designee or Contract Manager.

7. Be free of warranty information, unless authorized by WIC designed or Contract Manager.

8. Prior to printing, Contractor shall provide printed materials to WIC designee for approval within sixty (60) days after contract execution. WIC designee will review and provide written acceptance of the printed materials. Note: This will be documented and tracked using controlled correspondence, per Section 7.9 Controlled Correspondence.

a. All approved printed materials for each breast pump, shall be inserted into product or packaging prior to delivery.

7.1.7 Audio Visual and Media:

Instructional Video (including a DVD Master copy):

Criteria Response

1. Each multi-user and single-user electric pump shall have an instructional video and link to the online video on the following, at minimum:

• Assembly of milk collection kit.

• Attachment of milk collection kit to pump.

• Proper use of pump.

• Proper breast flange fitting.

• Cleaning of pump and milk collection kit.

2. Videos shall be free of mention or advertisement of infant feeding supplements and devices unrelated to contracted products unless authorized by WIC designee or Contract Manager.

3. Videos shall be available in English and Spanish.

4. Videos shall be closed captioned.

5. Contractor shall send videos to WIC designee for approval within sixty (60) days after contract execution. WIC designee will review and provide written acceptance of the printed materials. Note: This will be documented and tracked using controlled correspondence, per Section 7.9 Controlled Correspondence.

a. After final approval, Contractor shall provide an original video file in both English and Spanish, as MP4, Quick Time or Apple Pro Res to WIC designee.

b. Contractor shall provide written permission to WIC designee to duplicate videos as required. Note: This will be documented and tracked using controlled correspondence, per Section 7.9 Controlled Correspondence.

7.1.8 Warranty:

1. Contractor shall provide a minimum of three (3) years warranty for manufacturing defects on multi-user electric pumps.

a. Warranty period for multi-user pumps shall begin when the product is received by WIC Local Agency (LA) as indicated by the LA inventory report.

2. Contractor shall provide a minimum of one (1) year warranty for manufacturing defects on sterile milk collection kits and single-user electric pump, described in specifications and all associated products and materials.

a. Warranty period for sterile milk collection and single-user electric pump shall begin when the product is issued to the participant as indicated by WIC LA clinic issuance report(s).

3. Contractor shall provide a minimum of ninety (90) day warranty for manufacturing defects on manual pumps and additional sized breast flanges described in specifications.

a. Warranty period for manual pump and breast flanges shall begin when the product is issued to the participant as indicated by WIC LA clinic issuance report(s).

4. During warranty period, Contractor is responsible for repairing or replacing defective products with a new pump or parts (not refurbished) at no cost to HHSC or WIC LA. This includes but not limited to, cost associated with replacement parts, labor, shipping, and handling.

a. Repairs and replacements by the Contractor shall be completed and products returned to WIC LA within thirty (30) calendar days of Contractor receiving the product(s).

5. During warranty period, Contractor shall provide up to one hundred (100) insect de-infestation treatments on multi-user electric pumps per year at no cost to HHSC or WIC LA.

a. If maximum de-infestation treatment is reached, Contractor shall agree to accept in warranty and out of warranty infested pumps for disposal.

6. Breast pumps that are sent to Contractor for repair, de-infestation, cleaning and destruction, Contractor must provide a written receipt to WIC LA within three (3) business days upon receipt of the breast pump(s). Note: This will be documented and tracked using controlled correspondence, per Section 7.9 Controlled Correspondence.

7. Contractor shall agree to accept out of warranty or “excluded from warranty” products described in this solicitation for disposal at no cost to HHSC or WIC LA to contact third (3) party source. Note: This will be documented and tracked using controlled correspondence, per Section 7.9 Controlled Correspondence.

7.1.9 Replacement and Accessory Parts:

1. Be available to order throughout the life of the contract for WIC LA to order separately from Contractor.

2. Contractor shall keep in stock all replacements parts include but not limited to, coolers, or insulated carrying cases, electric outlet adapters, tubing, diaphragms, valves, flanges, vehicle adapters, and USB charges and ship within seven (7) business days of request by WIC designee or WIC LA.

7.1.10 Historical Annual Orders

See Exhibit I for Historical Annual Orders. Order quantities may vary and there is no guarantee on the amount, or the type of products purchased. HHSC reserves the right to increase or decrease quantities as needed.

7.1.11 Packaging

1. Multi-user and single-user pumps shall be packaged one (1) unit per shipping box.

a. Each multi-user shipping box shall be labeled on the outside with barcode which identifies the breast pump serial number and is easily readable by standard barcode reader. The label should:

i. Be color coded and easily distinguishable from other labels.

ii. Be easily visible and accessible for scanning.

2. Milk collection kits shall be packaged ten (10) unit per shipping box.

3. Manual pumps shall be packaged ten (10) unit per shipping box.

4. Additional sized breast flanges or breast flange sets shall be:

a. 31.0 mm or smaller shall be packaged twelve (12) units per shipping box.

b. Larger than 31.0 mm shall be packaged twelve (12) units per shipping box.

5. Contractor shall indicate units of products per shipping box on Pricing Sheet, see Exhibit H - Cost Proposal.

6. Each shipping box shall be clearly labeled on the outside with the product item number, name and quantity in box.

7.1.12 Shipping and Delivery

1. Contractor shall ship all orders to one (1) centralized shipping location. WIC designee or Contract Manager will provide shipping information at the time of order notification.

2. Vendor(s) shall fulfill each HHSC order as one (1) order.

3. HHSC requires delivery within forty-five (45) days after WIC designee or Contract Manager submits the order notification to the Contractor.

4. Contractor shall provide WIC designee and Contract Manager with shipping schedule to include delivery dates and quantities for review within two (2) business days after order notification.

Note: This will be documented and tracked using controlled correspondence, per Section 7.9 Controlled Correspondence.

a. WIC designee and/or Contract Manager shall review and provide written approval.

5. Contractor must notify WIC designee and Contract Manager of variances with the shipping schedule dates or quantities immediately as the Contractor becomes aware of all variances.

Note: This will be documented and tracked using controlled correspondence, per Section 7.9 Controlled Correspondence.

a. Variances and/or shipping errors are to be rectified by the Contractor at no cost to HHSC.

6. Contractor shall complete orders in full shipping boxes.

Partial orders will only be accepted if written authorization is granted by WIC designee or Contract Manager. Shipping box shall be clearly labeled on the outside with the product item number, name, and quantity in box.

7. Shipments that contain broken, damages or incomplete shipping boxes will be notated on the packing slip for replacement at no additional cost to HHSC. Note: This will be

8. A packing slip will include the corresponding purchase order number, product item number, name, and quantity and will accompany each delivery.

9. Freight shipped shall be on pallets. Pallets shall be stacked no higher than 50” high. Pallets shall not be stacked on top of one another.

a. Each pallet shall be clearly labelled and identify product item number, product name and total quantity in pallet.

b. Pallets shall be shrink wrapped.

c. Different product types shall not be mixed in the same shipping box or on the same pallet.

10. Contractor shall notify the designated contact at the shipping location by telephone and email two (2) days prior to delivery to confirm a tentative time and date of delivery. If delivery is attempted without notification or outside HHSC delivery hours, shipment may be refused at no cost to HHSC. Designated contact information and delivery hours will be provided by WIC designee and/or Contract Manager upon order notification.

11. Contractor shall notify WIC designee and Contract Manager within two (2) business days of any shipping discrepancies which may include shortages, overages or variances with dates or quantity. Note: This will be documented and tracked using

7.1.13 Samples

Respondent shall submit samples of products they choose to bid on as describe below. All samples may be provided in a separate package labeled “SAMPLES”. Respondent is responsible for ensuring the solicitation number and due date are clearly labeled on the outside of the package. Samples will not be returned.

Criteria Response Multi-User Electric Pump with caring case soft and hard case Sterile Milk Collection Kit for use with the Multi-User Electric Pump

Single-User Electric Pump and caring case Manual Pump Additional different sized breast flanges

7.1.14 Reporting

Contractor must submit an annual report to WIC designee and Contract Manager in an HHSC-approved format for the following: breast pumps repair, de-infestation, cleaning, destruction and out of warranty or “excluded from warranty products. Note: This will be documented and tracked using controlled correspondence, per Section 7.9 Controlled

HHSC may request more reports as needed.

7.8 Contractor Responsibilities

HHSC will look solely to the Contractor(s) for the performance of all contractual obligations resulting from an award based on this Solicitation. No Contractor will be relieved of its obligations for any nonperformance by its Subcontractor(s).

Criteria Response

a) The Contractor shall furnish all labor, tools, transportation, equipment, materials, and supplies, as necessary to perform the services and/or provide the goods, if applicable, as required.

b) Contractor must provide HHSC proof of marketing clearance for the multi-user and single user breast pumps thirty (30) days after contract execution to WIC designee and Contract Manager.

Note: This will be documented and tracked using controlled correspondence, per Section 7.9 Controlled Correspondence.

c)The Contractor shall provide training on how to utilize new breast pump(s) as requested by WIC designee. Note: This will be d)Contractor shall not directly market, solicit materials or communicate with WIC Ls unless prior written authorization is approved by WIC designee or Contract Manager or unless resolving warranty issues.

e) Contractor shall not include coupons, advertisement of infant feeding supplements, feeding or suckling devices unrelated to contracted products, or other promotional items in any of packaging, shipments, boxes unless prior authorization is provided by WIC designee or Contract Manager.

f) Contractor shall maintain a record of all insect’s de-infestations provided during the life of the contract. Record shall include WIC LA name and dates of service. Contractor shall provide such record(s) to WIC designee and/or Contract Manager upon request. Note: This will be documented and tracked using controlled correspondence, per Section 7.9 Controlled Correspondence.

g) Contractor shall designate a phone number and email address for Texas WIC services, thirty (30) days after contract execution and provide the information to WIC designee and Contract Manager. Note: This will be documented and tracked using

h) Contractor shall designate a representative to specifically provide technical assistance upon request by WIC designee.

Technical assistance shall include but not limited to, warranty issues, shipping discrepancies and special orders.

a. Contractor designated representative shall:

i. Be available Monday – Friday 8am-5pm CT, excluding federal holidays.

ii. Return emails, phone call requests and inquiries from HHSC and WIC LA within two (2) business days.

iii. Provide a solution to all inquiries or conflicts within five

(5) business days.

i) Contractor must have written customer service policies and procedures. These policies and procedures must be submitted within fifteen (15) days following the execution of the contract, and if applicable, any subsequent updates to WIC designee and Contract Manager for approval.

a. Contractor representative shall be knowledgeable of contracted services and warranty requirements.

b. Contractor representative must provide technical assistance to WIC Designee and WIC LA.

j) Contractor’s customer service policies and procedures, at a minimum, must include the following:

a. Guidelines for addressing customer inquiries, requests, compliments, and complaints in a prompt, responsive, and courtesy manner.

b. Expected service standards when communicating with customers e.g., in-person or via telephone, email, web chat, or other written correspondence; and

c. A description of the problem or incident resolution parameters and the Contractor’s escalation protocol.

d. Contractor must respond in a comprehensive manner to HHSC within one (1) Business Day of HHSC’s written inquiry regarding any customer service matter.

k) Contractor must notify WIC designee and Contract Manager by telephone and email within twenty-four (24) hours of the Contractor’s awareness of impending product recall. Note: This will be documented and tracked using controlled correspondence, per Section 7.9 Controlled Correspondence.

l) Contractor must collect and dispose of affected products and provide replacement at no cost to HHSC. This includes but not limited to, cost associated with replacement pumps, parts, labor, shipping, and handling fees.

1. Provide written notice of receipt of collected product(s) to WIC designee and WIC Local Agency clinic immediately upon receipt or recalled product(s). Note: This will be documented and tracked using controlled correspondence, per Section

7.9 Controlled Correspondence.