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Published: 2/09/2015

Invitation to Supply

Request For Tender

Part 5 - Statement of Requirements

Tender Number: HPVITS2015-018

Tender Name: Enteral Feeding and Oral Nutrition Support

Tender Closing Date and time:

Wednesday 30 September 2015, 14:00 AEST

Authorised Contact Person

Jared Tang

Category Manager

Contact through the HPV Procurement Portal

https://www.hpv.org.au

https://esourcing.hpv.org.au/

https://esourcing.hpv.org.au/

Table of Contents

Part 5 Statement of Requirements

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Enteral Feeding and Oral Nutrition Support HPVITS2015-018

Table of Contents

Invitation to Supply 1

Request For Tender 1

A Introduction 4

1. Purpose 4

2. Scope 4

3. Product Categories 4

4. Product Conditions 5

5. Definitions 7

B Statement of Work 9

1. Delivery 9

2. Urgent Deliveries 9

3. Home Enteral Nutrition 9

4. Home Delivery Services 10

5. Additional Information for HEN and Home Delivery Services 11

6. Training 11

7. Customer Service and Support 12

8. Key Performance Indicators 13

9. Reporting 13

10. Service Level Agreement 13

C General Requirements 15

1. Standards and Compliance 15

2. Packaging and Labelling 15

3. Recall Process 15

4. Backorders and Discontinued lines 16

5. Superseded Products 16

6. Shelf Life 16

7. Reference Sites 17

D Product Specifications 18

1. Substances of Concern 18

2. Compliance with Category Specifications 18

3. Food Safety Requirements 18

E Category Specifications 19

Category 1 - Enteral Formula Products 20

Additional Information 21

Category 2 - Oral Nutrition Support Products 22

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Category 3 - Thickened Beverage 24


Category 4 - Thickening Agents 26


Category 5 - Modular Products 28


Category 6 - Enteral Feed Administration Sets, Feeding Bags and Accessories 30

Provision of Enteral Feed Administration Sets 30

Additional Information: 30

Category 7 - Enteral Feeding Pumps 31

Power Supply 32

Construction Quality 33

Performance 33

Displays 33

Alarms 34

Marking Information 34

Enteral feeding pumps training requirements 34

Software Updates 35

Service and Parts 35

Warranty 36

Operating Manuals 36

Acceptance Testing 37


Category 8 - Nutritional Meal Replacement Products 38


Category 9 - Oral Dispensers 40

F Appendices 41

Appendix 1 - Product List 41

Appendix 2 - Standards, Guidelines and Other References 44

A 2.a Standards 44

A 2.b Legislation 44

A 2.c Guidelines and Other References 45

Appendix 3 - Reference Table of Subcategory Definitions 46

Introduction


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A Introduction

1. Purpose

a. The purpose of this Part 5 – Statement of Requirements, is to:

(i) detail the scope and range of products sought under this Request for Tender (RFT).

(ii) specify the requirements that Respondents and / or their offered products must meet

(these requirements also form part of any resulting Agreement between Health

Purchasing Victoria (HPV) and any successful Respondents).

2. Scope

a. HPV is seeking responses for Enteral Feeding and Oral Nutrition Support for use in

Participating Health Services (PHS). The envisaged Term of the Agreement is two (2) years

with two (2) possible two (2) year extension periods (2+2+2).

b. The scope of this RFT includes:

(i) supply of the products listed in section Part 5 -A3 - Product Categories.

c. The scope of this RFT does not include:

(i) infant formulae & special paediatric formulae;

(ii) enteral syringe pumps for neo-natal; and

(iii) integrated Enteral Feeding System.

d. Indicative volumes are listed in Part 6, Tender Response Worksheet (TRW).

3. Product Categories

a. The categories of Enteral Feeding and Oral Nutrition Support required under this RFT

include:

(i) Category 1 – Enteral Formula Products;

(ii) Category 2 – Oral Nutrition Support Products;

(iii) Category 3 – Thickened Beverages;

(iv) Category 4 – Thickening Agents;

(v) Category 5 – Modular Products;

(vi) Category 6 – Enteral Feed Administration Sets, Feeding Bags and Accessories;

(vii) Category 7 – Enteral Feeding Pumps;

(viii) Category 8 – Nutritional Meal Replacement Products; and

(ix) Category 9 – Oral Dispensers

b. Respondents may offer products in one, some or all categories.

c. Preference to offers with the greatest range and best value for money across and/or within

product categories (with the exception of niche product ranges) may be given.

d. Only products that specifically fit within the category description provided will be considered.

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e. HPV reserves the right not to consider any additional products offered.

f. For a full list of product categories and subcategories, see Appendix 1 - Product List.

4. Product Conditions

4.1. Clinical Trials

a. PHS may, at their discretion, research or trial new technology or use non-contracted

products to perform clinical trials at any time during the term of any resulting Agreement.

4.2. Product Duplication

a. HPV will not consider any product that is subject to a current HPV Agreement, other than

the current Agreement HPVC2011-018 for this category.

b. Respondents are to ensure each product is offered in only one subcategory.

c. It is the Respondent’s responsibility to ensure that each product is submitted in the most

appropriate subcategory.

4.3. Product Information

a. Respondents must submit a copy of relevant product diagrams, specifications or brochures

to assist in accurately identifying products offered.

b. All product information submitted must:

(i) be in electronic format;

(ii) be in English;

(iii) be specific to the product offered;

(iv) contain the Respondents’ company name;

(v) include the product code;

(vi) include a detailed specification of the product; and

(vii) include clear diagrams/pictures of the product.

c. To assist in managing this material, all product information submitted must be identified with

the relevant HPV category and subcategory number in the file name or identifying metadata.

HPV reserves the right not to consider any non-identified submissions.

d. Product information will not be evaluated, but is necessary to assist in accurately identifying

products offered.

e. Where offered products are unidentifiable and the product information provided is not clearly

labelled, HPV reserves the right to remove these products from evaluation.

f. Respondents are not to submit information relating to products that are not called for in this

RFT.

g. Samples are required for all products tendered by current contract incumbent suppliers as

follows:

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(i) For new products not currently supplied in the current contract or previously tendered;

(ii) Category 8 – Nutritional Meal Replacement Products; and

(iii) Category 9 - Oral Dispensers.

h. Samples are required for all products tendered by new suppliers in all categories.

i. No other samples are required unless called upon during the tender evaluation process.

Where Respondents are requested to provide samples of their products for evaluation

purposes, they should include:

(i) two (2) samples for each range or sub-category;

(ii) one (1) sample of each product size tendered preferably the smaller pack sizes;

(iii) a list of all samples provided; and

(iv) instructions for use, where applicable.

j. All samples provided must:

(i) be new and unopened;

(ii) include supporting specifications and relevant data; and

(iii) be representative of the current packaging and labelling.

k. Each sample submitted must be clearly labelled with the following information:

(i) name of the Respondent;

(ii) RFT name and number;

(iii) name and number of the sub-category that the product has been tendered into; and

(iv) product code and description.

l. If sample of a new (i.e. not currently on contract) pump is provided for evaluation, it should

include:

(i) a compatible enteral feed administration set;

(ii) an empty fluid bag or equivalent for connection to the administration set;

(iii) one copy of the enteral feeding pump operator manual; and

(iv) one copy of the enteral feeding pump technical maintenance manual.

The new pump samples shall be collected from HPV by the Respondents during the week

beginning 2 November 2015.

m. All other samples submitted will be disposed of upon completion of the evaluation process.

Samples may be returned at Respondent’s cost if required.

n. Samples are to be addressed to:

Attention to: Jared Tang

HPVITS2015-018

Health Purchasing Victoria

Level 34, 2 Lonsdale Street

Melbourne, VIC 3000

o. All samples are to arrive at this address before the tender Closing Date and Time.

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5. Definitions

a. The following definitions apply to this Part 5 – Statement of Requirements, unless otherwise

stated.

Term Definition

Agreement The Agreement between HPV and a successful Respondents whether in draft or otherwise.

business day Any weekday that is not gazetted as a public holiday in Melbourne, Victoria.

consumable A component that is used continually until it is exhausted and needs to be replaced.

FODMAPs Fermentable Oligo-, Di-, Mono-saccharides And Polyols.

GMDNS Global Medical Device Nomenclature System.

GS1 The organisation Global Standards One.

GTIN Global Trade Identification Number.

HEN Home Enteral Nutrition.

HDS Home Delivery Service. The service of oral products to the home, other than

HEN.

HPV Health Purchasing Victoria.

may Indicates an optional element; it is at the Respondent’s discretion to either meet or not meet this element, and failure to meet this element will not have an impact during evaluation.

must Indicates a mandatory requirement; failure to meet this requirement will have a significant negative impact during evaluation.

normal use Indicates that the item has undergone use for which it was manufactured and

intended, and shows no signs of physical damage other than regular wear and

tear.

NPC National Product Catalogue.

OEM Original Equipment Manufacturer.

PHS Participating Health Services - Public Hospitals and other Health or Related Services, as those terms are defined in Section 3 of the Health Services Act 1988 (Vic), that are described in Appendix 4 of Part 8.

Respondent Any person, company or organisation responding to this ITS and, unless the

context otherwise requires, includes those who may access the ITS for

submitting a Tender.

RDI Recommended Daily Intake

https://en.wikipedia.org/wiki/Gut_flora#Carbohydrate_fermentation_and_absorption

https://en.wikipedia.org/wiki/Oligosaccharide

https://en.wikipedia.org/wiki/Disaccharide

https://en.wikipedia.org/wiki/Monosaccharide

https://en.wikipedia.org/wiki/Monosaccharide

https://en.wikipedia.org/wiki/Polyol

Introduction


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Term Definition

RFT Request for Tender.

Shelf Life The date indicator listed on products, whether it is listed as Best Before, Use By or another term.

should Indicates a highly desirable element; unless justifiable reason exists, not meeting this element may have a degree of impact during evaluation.

single use A device that is intended to be used on an individual patient, during a single procedure, and then discarded. (Source: TGA, Regulation of the Re-Manufacture of Single Use Medical Devices).

single-patient use A device that can potentially undergo more than one episode of use on one patient only. The device may need to undergo some form of reprocessing between each use (in accordance with manufacturers’ instructions). (Source: TGA, Regulation of the Re-Manufacture of Single Use Medical Devices).

SLA Service Level Agreement.

TGA Therapeutic Goods Administration.

TRW Tender Response Worksheet.

update In relation to the equipment, means any software or hardware supplied by the supplier which has been produced primarily to improve the operation of the equipment (including bug fixes and patches) without significantly improving the functionality or performance of the Equipment;

upgrade In relation to the equipment, means any software or hardware supplied by the supplier which has been produced primarily to extend, alter or improve the equipment by providing additional functionality or performance enhancements.

will Indicates an anticipated future condition or requirement.

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B Statement of Work

1. Delivery

a. Enteral Feeding and Oral Nutrition Support products must be delivered within two (2)

business days by the Participating Health service from receipt of order unless otherwise

agreed.

b. Except where there is evidence of inappropriate handling by the receiving PHS, all damaged

or broken products and equipment must be replaced free of charge.

2. Urgent Deliveries

a. For the purposes of this section, urgent deliveries refers to urgent requests placed by an

individual PHS, and does not include state-wide emergency situations.

b. Respondents must be able to receive and action urgent deliveries.

c. Urgent deliveries must be received by PHS within the shortest possible timeframe. This

should be within 24 hours from the receipt of order.

3. Home Enteral Nutrition

a Home Enteral Nutrition (HEN) services are required to meet the differing needs of clients

managed by the Victorian health services. HEN services shall be scalable and flexible to

meet the requirements for:

(i) Category 1: Enteral Formula Products;

(ii) Category 6: Enteral Feed Administration Sets, Feeding Bags and Accessories;

(iii) Category 7: Enteral Feeding Pumps;

(iv) Category 9: Oral Dispensers;

(v) home patient support and education; and

(vi) order placement, invoicing and communication.

b Successful Respondents shall ensure that service and/or educational personnel do not

discuss or suggest other products or devices to HEN clients, other than those products or

devices that they have been requested to support by the PHS. They are not to distribute

product marketing brochures and pamphlets to HEN clients.

c Respondents shall provide the following information on the Tender Response Worksheet

(TRW):

(i) prices for the provision of products offered for HEN services.

d Respondents shall advise in their response:

(ii) an outline of all HEN services offered; and

(iii) any additional charges (excluding product) associated with their provision including

any delivery charges.

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e Where differing levels, programs or complexity of service are offered, the costs and contents

of each level of service shall be clear.

f HEN Products:

(i) all products offered as part of a HEN service shall meet the specifications stated in

this Request for Tender document.

(ii) where enteral feeding pumps are offered as part of the HEN service, Respondents

shall provide the following information in their response:

I. the method and all conditions associated with the provision of pumps;

II. all costs associated with the provision and maintenance;

III. arrangements for maintenance and repair including timing for replacement of

defective or ageing equipment;

IV. the availability of loan pumps, at no charge, in the event of pump malfunction;

V. the training program provided for safe use including trouble shooting;

VI. management and reporting of pump inventory provided to individual hospitals or

health services; and

VII. any documents used for ordering or that provide information on the HEN

management process.

4. Home Delivery Services

a. Home Delivery Services (HDS) consists of oral products excluding Home Enteral Nutrition

(HEN) services. HDS is required to meet the differing needs of clients managed by Victorian

health services. HDS shall be scalable and flexible to meet the requirements for:

(i) Category 2: Oral Nutrition Support Products;

(ii) Category 3: Thickened Beverages;

(iii) Category 4: Thickening Agents;

(iv) Category 5: Modular Products;

(v) Category 8: Nutritional Meal Replacement Products; and

(vi) order placement, invoicing and communication.

b. Successful Respondents shall ensure that service and/or educational personnel do not

discuss or suggest other products or devices to HDS clients, other than those products or

devices that they have been requested to support by the PHS. They are not to distribute

product marketing brochures and pamphlets to HDS clients.

c. Respondents shall provide the following information on the Tender Response Worksheet:

(i) prices for the provision of products offered for Home Delivery services.

d. Respondents shall advise in their response:

(i) an outline of all Home Delivery Services offered; and

(ii) additional charges, including delivery charges associated with their provision. This

excludes product charges.

e. Where differing levels, programs or complexity of service are offered, the costs and contents

of each level of service shall be clear.

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f. All products in the categories stated in clause 4a offered as part of the Home Delivery

Service (HDS) shall meet the specifications as stated in this Request for Tender document.

g. Respondents shall provide the following information in the Tender Response Worksheet

(TRW):

(i) Any documents:

I. used for ordering; and

II. that provide information on the home delivery service management process.

5. Additional Information for HEN and HDS

5.1. Ordering of Products

a. Respondents shall provide the following information in their response on the processes by

which:

(i) a new home patient is established including relevant timelines for delivery;

(ii) orders are to be placed and acknowledged;

(iii) backorders of products are managed including communication of issues and any

contingency arrangements; and

(iv) service to a home patient is terminated.

5.2. Delivery Service

(i) deliveries made direct to clients at their homes shall occur following receipt of a

purchase order or communication from the specific hospital or health service via an

agreed process e.g. a standing order.

(ii) facilities shall be available for the receipt of purchase orders five (5) business days

per week (Monday to Friday) excluding Public Holidays.

(iii) preference will be given to companies that can deliver goods within 48 hours of

receipt of a purchase order to all metropolitan and regional centres.

(iv) Respondents shall provide the following information in their response:

I. the maximum time (in hours) from the time and date of receipt of the Purchase

Order to completion of delivery; and

II. whether delivery applies to all Victorian regions, or where there are any limitations

to delivery times, please state these limitations.

6. Training

a. Upon request by a PHS, successful Respondents must deliver a training package and/or

training material to facilitate the introduction of their products to clinicians in their operating

environment.

b. Training material should comply with Standard 3 of the National Safety and Quality Health

Service Standards – Appendix 2 - Standards, Guidelines and Other References.

c. Training requirements may include (but are not limited to):

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(i) face-to-face training at PHS sites and other care settings, including homes (i.e. in-

service training);

(ii) off-site training days for clinicians;

(iii) updates and refresher training on products; and

(iv) training materials.

d. Training must be provided for the provision of Enteral Feeds Pumps.

e. If requested by a PHS, successful Respondents must provide an education plan detailing

how they will provide training to nominated staff. Note that the number of staff involved in

training may vary greatly between each PHS. Successful Respondents shall provide

education and support programs, including educational material that may assist hospitals in

training of home patients. Successful Respondents must ensure that the following is

available to the PHS (in hard-copy and electronic format):

(i) the credentials of any staff who would be providing support including a Police Check

and where applicable a Working with Children Check;

(ii) the hours of availability for support;

(iii) the geographical area covered by the support (if support is available on-site); and

(iv) details of educational and/or support materials available to clinicians.

f. Where a home consultant service is offered, Respondents shall provide the following

information:

(i) the range of services provided by the home consultant service and any costs

associated with its use;

(ii) the clearly defined scope of services to be provided including responsibilities, specific

procedures and communication of issues, between the health service and the home

consultant service;

(iii) the credentials of the home consultant for the education and support programs

offered; and

(iv) any costs associated with the range of services provided by the home consultant

service.

g. All training regimes must include appropriate levels of training to meet Workplace Health &

Safety standards as required by the Victorian WorkCover Authority.

7. Customer Service and Support

a. Successful Respondents must be able to deliver prompt customer service and support to

the PHS.

b. Successful Respondents must nominate at least one representative as the key account

manager to work closely with the PHS and HPV.

c. Successful Respondents must provide PHS with representatives that are:

(i) inherently familiar with the contracted products;

(ii) appropriately qualified for the service to be performed;

(iii) technically/clinically knowledgeable about the contracted products;

(iv) available to respond to PHS queries during business hours; and

(v) PHS may require representatives to pass a Police Check and Working With Children

Check.

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d. The level of customer service and support required of Representatives is expected to

include (but is not limited to):

(i) liaising with clinicians to recommend products and solutions;

(ii) promptly answering of clinicians’ queries;

(iii) liaising with various hospital departments (e.g. Clinical Product Advisors, Nurse Unit

Managers);

(iv) providing on-site clinical support (if requested); and

(v) providing informational and training materials.

8. Key Performance Indicators

a. Key Performance Indicators are included in Schedule 6 of Part 7 Draft Agreement -

Performance Indicators.

9. Reporting

a. Refer to Schedule 7 of Part 7 Draft Agreement - Reporting Requirements.

b. Successful Respondents must provide to HPV other reports that may reasonably be

required from time to time.

10. Service Level Agreement

a. Successful Respondents may enter into a Service Level Agreement with individual hospitals

or health services requiring the provision of ‘free on loan’ enteral feeding pumps and/or a

Home Enteral Nutrition (HEN) service.

b. The agreement shall cover all arrangements as described in Category 7 – Clause b,

including but not limited to:

(i) provision of enteral feeding pumps, feeding bags, pump driven and/or gravity driven

feeding sets;

(ii) product and equipment support including education, trouble-shooting, stock

management and rotation;

(iii) arrangements for ordering and invoicing;

(iv) communication requirements for establishment, ongoing management and cessation

of individual home patients;

(v) provision of home consultant services; and

(vi) any additional costs associated with provision of the home consultant service.

c. Where a hospital or health service receives pumps under the ‘free on loan’ option and

chooses to undertake any of the above listed responsibilities of the successful Respondent:

(i) the overarching responsibility for pump maintenance and tracking remains with the

Successful Respondent; and

(ii) the hospital or health service shall clearly identify in the Service Level Agreement,

which party will be undertaking which tasks.

d. PHS Service Level Agreement (SLA) with the successful Respondents may cover other

arrangements including, but not limited to:

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(i) requirements for stock management and rotation;

(ii) arrangements for ordering, invoicing and delivery;

(iii) clinical support, including attendance requirements for Representatives in relation to

education and training; and

(iv) communication arrangements for product recalls and safety alerts (refer to Part 5 -C3

- Recall Process).

e. The SLA will be in addition to the Agreement between the successful Respondents and

HPV, and will not alter any terms of the Agreement.

f. Successful Respondents must provide a copy of all Service Level Agreements to HPV within

one (1) week of the SLA being finalised.

g. HPV will not be responsible for monitoring compliance with any SLA. This is a matter of

agreement between the parties to the SLA.

General Requirements


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C General Requirements

1. Standards and Compliance

a. All items offered must comply with relevant Australian Standards (or their equivalent

International Standards). Refer to Appendix 2 - Standards, Guidelines and Other

References for a list of the minimum relevant standards.

b. All items offered must be approved by the Australian Therapeutic Goods Administration

(TGA), unless exempt. The Respondents must provide evidence of this (i.e. ARTG number)

on the Tender Response Worksheet.

c. The successful Respondents must provide evidence of ARTG certification to Participating

Health Services upon request.

2. Packaging and Labelling

a. Products must be packaged to retain the structural integrity of the enclosed product.

b. Sterile products must be packaged in a manner that protects the contents from

contamination during transportation, storage and handling.

c. All labels must comply with the Therapeutic Goods Order No. 37: General Requirements for

Labels for Therapeutic Goods. All product names and codes must be in English and clearly

visible on the product pack or labels.

d. Shelf Life date information, in the form of Use By or Best Before etc. must be clearly visible

on individual product packaging.

e. Items must be delivered in accordance with the manufacturer’s instructions.

f. It is a requirement for individual product packaging to include (where applicable):

(i) whether the product is sterile;

(ii) whether the product (or packaging) contains latex or is latex-free; and

(iii) identifiers for manufacturing batch and expiry date.

3. Recall Process

a. All recalls must be managed in line with the Uniform Recall Procedure for Therapeutic

Goods (2004).

b. Within six (6) months of contract commencement, all recalls and/or hazard alerts must be

completed using GS1 Recallnet.



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4. Backorders and Discontinued lines

a. In the event that a product is unavailable, successful Respondents must immediately

contact the affected PHS (at a minimum):

(i) supply departments; and

(ii) the Clinical Products Advisor (where applicable).

b. In the event that a product is unavailable for a period of two (2) or more consecutive weeks,

successful Respondents must also contact:

(i) Health Purchasing Victoria (HPV).

c. In the event that an item is discontinued, successful Respondents must notify all PHS staff

and HPV (as listed in clause 5b) as soon as possible, but no less than six (6) months before

the last date of supply to the PHS.

d. Successful Respondents must inform the affected Participating Health Services and HPV of:

(i) anticipated timeframe for resolving the supply issue; and

(ii) availability of agreed substitute products.

e. Successful Respondents must provide PHS with regular reports on out of stock and stock at

risk. The frequency of reporting will be decided by the respective PHS.

5. Superseded Products

a. Where a contracted item is superseded, the new product must be offered at the same price

as the original item. This change request must be submitted to HPV for approval.

6. Shelf Life

a. Products must have a clearly shown documented Shelf Life date. This is in the form of the

appropriate industry requirement or standard of either a Use-By or Best Before date or

similar.

b. All enteral formula products shall have a minimum four-month Shelf Life date from receipt of

goods by the PHS. Where products have a Shelf Life date shorter than four months,

successful Respondents shall notify the Health Service prior to delivery. In this instance, the

Health Service reserves the right to accept or reject the product.

c. The Shelf Life date requirement applies to perishable products in the following categories:

(i) Category 1 – Enteral Formula Products;

(ii) Category 2 – Oral Nutrition Support Products;

(iii) Category 3 – Thickened Beverages;

(iv) Category 4 – Thickening Agents;

(v) Category 5 – Modular Products; and

(vi) Category 8 – Nutritional Meal Replacement Products.



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7. Reference Sites

a. Respondents are required to provide a minimum of three (3) Australian clinical references

that are either purchasing the product or have trialled and evaluated the product offered in

this submission, unless the product offered is currently on the HPV contract HPVC2011-018

Enteral Feeds.

b. Where a product category contains a variety of specific sub-categories, Respondents are to

ensure that the clinical references provided are representative of the full range of products

tendered.

c. HPV reserves the right to verify this information with health services personnel and seek

user feedback as to the acceptability of these products.

d. Respondents should not nominate a referee without their express permission.

Product Specifications


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D Product Specifications

1. Substances of Concern

a. Preference will be given to products (including accompanying packaging) that are latex-free,

unless otherwise stated.

b. Preference will be given to products (including delivery products and accompanying

packaging in contact with the products) that are free from phthalate content, particularly

diethyl-2-hexylphthalate (DEHP).

2. Compliance with Category Specifications

a. Products offered with optional components must also comply with the specifications for

other relevant categories (where applicable).

3. Food Safety Requirements

a. All products tendered (with the exception of Categories 6, 7 and 9) shall:

(i) comply with the requirements of the Australian New Zealand Food Standards

(including amendments);

(ii) be endorsed as “Food Safe” under HACCP Australia Guidelines; and

(iii) be supplied from registered food premises.

b. Copies of HACCP certificates shall be provided as an attachment:

(i) with each tender submission, for posting in the restricted customer only access area

of the HPV website (successful Respondents only) along with pricing schedules and

user guide information; and

(ii) to hospitals and health services on request throughout the life of any resulting

contracts.

Category Specifications


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E Category Specifications

A complete range of Enteral Feeding and Oral Nutrition Support products is required for

treatment of patients across Victorian Participating Health Services.



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Category 1 - Enteral Formula Products

A full range of enteral formula is required to meet clinical needs. This includes:

(i) for in-patients and as part of the Home Enteral Nutrition (HEN) Services;

(ii) for adult and paediatric patients;

(iii) to suit all clinical conditions;

(iv) a full range of energy levels;

(v) liquid, powder, ‘ready to use’ and ‘ready to hang’ formats;

(vi) low, standard and high protein formulas;

(vii) with and without added fibre; and

(viii) low sodium, low carbohydrate, peptide and amino acid-based products.

Where enteral formula products claim to be nutritionally complete they shall provide 100% b

RDI for a male of 31-50 years in a defined volume, as described in "Nutrient Reference

Values for Australia and New Zealand" as endorsed by the National Health and Medical

Research Council on 9 September 2005.

Where enteral formula products are tendered specifically for paediatric use and claim to be c

nutritionally complete, they shall provide 100% RDI for a child of 4-8 years of age in a

defined volume, as described in "Nutrient Reference Values for Australia and New

Zealand" as endorsed by the National Health and Medical Research Council on 9

September 2005.

Respondents are advised to refer to Appendix 3 - Reference Table of Subcategory d

Definitions.

Where products are presented in a powdered form, response information regarding e

nutritional content shall be based on the standard dilution and state the standard dilution

volume in millilitres.

For all enteral formula products offered, Respondents shall provide the following information f

in the product description on the Tender Response Worksheet:

(i) brand name;

(ii) volume in millilitres;

(iii) weight in grams;

(iv) percentage of dilution;

(v) weight of scoop measure in grams (where applicable); and

(vi) product packaging type i.e. ready to hang, glass, plastic, tetrapak, can.

For all enteral formula products offered, Respondents shall provide the following information g

on the Tender Response Worksheet:

(i) kilojoules provided per 100 ml of feed and per unit;

(ii) the volume and cost per day to achieve 100% recommended daily intake (RDI) as

described in Category 1, clauses 1b and 1c;

(iii) the price per kilojoule for each presentation, calculated on the base price tendered;

(iv) protein content, as a percentage of total energy provided, in grams per Litre and per

unit;

(v) carbohydrate content, as a percentage of total energy provided, and in grams per unit

and in grams per Litre;

(vi) electrolyte content of sodium and potassium, in milligrams per Litre;

(vii) water in millilitres per litre;

(viii) fibre content, in grams per Litre and type of fibre;



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(ix) where enteral formula products are offered for consumption by patients with specific

medical conditions, list other specific nutrients in milligrams per Litre, required for the

medical condition;

(x) osmolality, in milliosmoles per kilogram water;

(xi) presence or absence of:

I. lactose;

II. gluten;

(xii) presence of FODMAPs, specifically:

I. Fructose, Fructans, Raffinose;

II. Inulin;

III. Polyols-sorbitol, Xylitol;

(xiii) glycaemic index, where available;

(xiv) whether the product is nutritionally complete;

(xv) Kosher compliant;

(xvi) Halal compliant; and

(xvii) suitability for individuals on a vegan diet.

Additional Information

The following information shall be available to all contract users via hard copy and electronic a

means:

(i) a complete nutritional composition profile for each product;

(ii) an ingredient composition list which identifies as a minimum, the source(s) of protein,

fats, carbohydrate and fibre included in each product; and

(iii) a list of deficiencies where enteral formula products are not nutritionally complete.



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Category 2 - Oral Nutrition Support Products

A range of oral nutrition support products is required to meet clinical needs for nutritional a

supplementation. This includes:

(i) for in-patients and as part of the Home Delivery Service ;


(iii) a full range of:

I. energy levels; and

II. flavours;

(iv) a full range of liquids, powders, puddings and bars which includes:

I. milk and non milk type;

II. peptide based; and

III. with and without added fibre;

Where the thickness of oral nutrition support products has been modified to facilitate b

consumption by patients with swallowing difficulties, Respondents are advised to offer these

products in Category 3 - Thickened Beverages.

Where oral nutrition support products are claimed to be nutritionally complete they shall c

provide 100% RDI for a male of 31-50 years of age in a defined volume, as described in

"Nutrient Reference Values for Australia and New Zealand" endorsed by the National Health

and Medical Research Council on 9 September 2005.

Where oral nutrition support products are tendered specifically for paediatric use and are d

claimed to be nutritionally complete, they shall provide 100% RDI for a child of 4-8 years of

age in a defined volume, as described in "Nutrient Reference Values for Australia and New

Zealand" as endorsed by the National Health and Medical Research Council on 9

September 2005.

Where oral nutrition support products are presented in a powdered form, response e

information regarding nutritional content shall be based on the standard dilution and state

the standard dilution volume in millilitres.

For all oral nutrition support products offered, Respondents shall provide the following f

information in the Product Description on the Tender Response Worksheet:

(i) brand name;

(ii) presentation type i.e. ready to drink, powder, concentrate, pudding, bar;

(iii) product packaging type i.e. glass bottle, plastic bottle, plastic wrap, tetrapak, can,

plastic cup;

(iv) volume in millilitres; or

(v) weight in grams;

(vi) weight of scoop measure in grams (where applicable); and

(vii) flavour;

For all oral nutrition support products offered, Respondents shall provide the following g

information on the Tender Response Worksheet:

(i) kilojoules provided per 100 ml or 100 grams of supplement and per unit;


described in clauses Category 2 - clauses b and c;




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(iv) protein content, as a percentage of total energy provided, in grams per litre and per

unit;

(v) carbohydrate content, as a percentage of total energy provided, in grams per unit,

and grams per Litre;

(vi) electrolyte content of sodium and potassium in milligrams per Litre;

(vii) fibre content, in grams per litre and type of fibre;

(viii) where oral nutrition support products are offered for consumption by patients with

specific medical conditions, list other specific nutrients in milligrams per Litre, required

for the medical condition;

(ix) osmolality, in milliosmoles per kilogram water;

(x) presence or absence of:

I. lactose;

II. gluten;

(xi) presence of FODMAPs, specifically:


II. Inulin;


(xii) glycaemic index, where available;

(xiii) whether the product is nutritionally complete;

(xiv) Kosher compliant;

(xv) Halal compliant;

(xvi) suitability for individuals on a vegan diet; and

(xvii) if packaging is resealable.



means:


(ii) an ingredient composition list which identifies as a minimum, the source/s of protein,


(iii) where oral nutrition support products are not nutritionally complete, list the

deficiencies.



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Category 3 - Thickened Beverage

A range of pre-packed, ready-to-use thickened beverages is required for consumption by a

patients with swallowing difficulties. This includes:

(i) for in-patients and as part of a Home Delivery Service;

(ii) for nutritional supplementation and hydration;

(iii) a full range of thicknesses;

(iv) a full range of flavours; and

(v) a range of bases including water, cordial, fruit juice, milk-type, tea, coffee and other.

Thickened beverages are sought under the following levels: b

(i) Level 150 – Mildly thick;

(ii) Level 400 – Moderately thick; and

(iii) Level 900 – Extremely thick.

Preference shall be given to Respondents who comply with the Australian Standardised c

Terminology and Definitions for Texture Modified Foods and Fluids 2007 (Nutrition &

Dietetics 2007; 64 (Suppl. 2): S53/S76).

All tendered thickened beverages shall comply with Australian New Zealand Food d

Standards Code 1.2.9: Legibility Requirements.

Where thickened beverages are claimed to be nutritionally complete they shall provide e

100% RDI for a male of 31-50 years of age in a defined volume, as described in Nutrient

Reference Values for Australia and New Zealand endorsed by the National Health and

Medical Research Council on 9 September 2005.

Where oral nutrition support products are tendered specifically for paediatric use and are f

claimed to be nutritionally complete, they shall provide 100% RDI for a child of 4-8 years of

age in a defined volume, as described in Nutrient Reference Values for Australia and New

Zealand as endorsed by the National Health and Medical Research Council on 9 September

2005.

For all thickened beverages offered, Respondents shall provide the following information in g

the Product Description on the Tender Response Worksheet.

(i) brand name;


(iii) level of thickness e.g. Level 150;

(iv) colour code of pack e.g. green;

(v) size of the font for the level of thickness in millimetres e.g. 3mm;

(vi) type of base e.g. water, fruit juice;

(vii) flavour; and

(viii) product packaging type i.e. plastic bottle, plastic cup, tetrapak, can.

For all thickened beverages offered, Respondents shall provide the following information in h

the Product Description on the Tender Response Worksheet.

(i) kilojoules provided per 100 ml of thickened beverage and per unit;


described in Category 3 - clauses e and f;

(iii) price per kilojoule for each presentation, calculated on the base price tendered;

(iv) whether the product is nutritionally complete;



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(v) protein content, as a percentage of total energy provided, in grams per unit and

grams per Litre;

(vi) carbohydrate content, as a percentage of total energy provided, in grams per unit,


(vii) electrolyte content of sodium and potassium in milligrams per Litre;

(viii) fibre content, in grams per litre and type of fibre;

(ix) the presence or absence of:

I. lactose;

II. gluten;

(x) presence of FODMAPs, specifically:


II. Inulin;


(xi) glycaemic index, where available;

(xii) Kosher compliant;

(xiii) Halal compliant;

(xiv) suitability for individuals on a vegan diet; and

(xv) if packaging is resealable.



means:

(i) a complete nutritional composition profile for each product; and

(ii) an ingredient composition list that identifies at a minimum, the source/s of protein,

fats, carbohydrate and fibre included in each product.



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Category 4 - Thickening Agents

Thickening agents are required to modify the consistency of oral fluids for consumption by a

patients with swallowing difficulties. This includes:

(i) for in-patients and as part of a Home Delivery Service; and

(ii) a full range of packaging sizes.

When thickening agents are used in accordance with the manufacturer’s instructions, the b

modified fluid shall retain a stable consistency i.e. within the consistency range to which it

was prepared, over a 24 hour period.

Thickening agents shall incorporate clear instructions for use including: c

(i) the type of fluids to which the thickening agent can be added;

(ii) the dosage levels required to achieve different consistency levels across the range of

fluids;

(iii) cost to achieve different consistency levels across the range of fluids; and

(iv) the mode of preparation e.g. blender.

For all thickening agents offered, Respondents shall provide the following information in the d

Product Description on the Tender Response Worksheet:

(i) brand name;

(ii) presentation e.g. powder or liquid;

(iii) volume in millilitres; or

(iv) weight in grams; and

(v) weight of the scoop measure in grams (where applicable).

For all thickening agents offered, Respondents shall provide the following information on the e

Tender Response Worksheet:

(i) kilojoules provided per 100 ml of thickened beverage;

(ii) carbohydrate content is per 100 grams;

(iii) fibre content, in grams per litre and type of fibre;

(iv) the presence or absence of:

I. lactose;

II. gluten;

(v) presence of FODMAPs, specifically:


II. Inulin;


(vi) Kosher compliant;

(vii) Halal compliant; and

(viii) suitability for individuals on a vegan diet.




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means:

(i) an ingredient composition list which identifies at a minimum, the source/s of the

thickening agent.



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Category 5 - Modular Products

A full range of modular products is required to meet clinical needs. This includes: a

(i) for both in-patients and as part of Home Delivery Services;

(ii) glucose polymers including liquid and powder presentations;

(iii) fibre powder; and

(iv) fat emulsions, including medium and long chain triglyceride oil;

(v) protein powder;

(vi) combination products including glucose polymer/fat.

For all modular products offered, Respondents shall provide the following information in the b


(i) brand name;

(ii) presentation e.g. liquid or powder;

(iii) volume in millilitres, or

(iv) weight in grams;

(v) flavour, where applicable;

(vi) the weight of the scoop measure in grams (where applicable); and

(vii) percentage dilution.

For any glucose polymer offered, Respondents shall provide the following information on the c


(i) the energy level in kilojoules per 100 grams or kilojoules per 100 millilitres;

(ii) the carbohydrate content in grams per 100 grams or grams per 100 millilitres; and

(iii) the protein content in grams per 100 grams or grams per 100 millilitres.

For any fibre powder offered, Respondents shall provide the following information on the d



(ii) the fibre content in grams per 100 grams; and

(iii) the fibre source.

For any fat emulsions offered, Respondents shall provide the following information on the e



(ii) the carbohydrate content in grams per 100 grams or grams per 100 millilitres;

(iii) the type/s of fat; and

(iv) the percentage of each type of fat as total fat content.

For any protein powder offered, Respondents shall provide the following information on the f

Tender Response worksheet:


(ii) the protein content in grams per 100 grams; and

(iii) the protein source.



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For any combination products offered, Respondents shall provide the following information g

on the Tender Response worksheet:


(ii) the glucose polymer/fat content in grams per 100 grams; and

(iii) the glucose polymer/fat source.

For all modular products offered, Respondents shall provide the following information on the h


(i) the presence or absence of:

I. lactose;

II. gluten;

(ii) presence of FODMAPs, specifically:


II. Inulin;


(iii) Kosher compliant;

(iv) Halal compliant; and

(v) suitability for individuals on a vegan diet.



means:





deficiencies.



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Category 6 - Enteral Feed Administration Sets, Feeding Bags and

Accessories

A range of enteral feeding equipment is necessary to meet requirements in the hospital and a

home setting. This includes:

(i) pump-driven and gravity-driven administration sets;

(ii) feeding bags with and without integral administration sets;

(iii) connectors and adaptors including universal adaptors; and

(iv) accessories to facilitate the provision of enteral feed administration.

Enteral feed administration sets shall incorporate at a minimum: b

(i) a distal connector to allow connection with commercially available ready-to-hang

enteral feeds or feeding containers;

(ii) kink resistant tubing; and

(iii) a proximal connector at the patient end to allow connection with the patient feeding

tube.

Enteral administration feed sets shall not be compatible with intravenous or hypodermic c

access devices.

Provision of Enteral Feed Administration Sets

Enteral feed administration sets shall be offered under the following pricing model in the a


(i) whether sets are compatible to specific pump manufacturers;

(ii) outright purchase of pump: for use where the customer owns the enteral feeding

pumps with which the sets are to be used; and

(iii) pump provided ‘free-on-loan’: for use where enteral feeding pumps are being

provided without charge for use by the associated sets .

Additional Information:

The following information shall be readily available to all contract users via hard copy and a

electronic means:

(i) a description and/or diagram of each pump set offered which identifies all features

including roller clamps, 3-way taps and Y-sites; and

(ii) a list detailing the compatibility of each enteral feed administration set offered with the

range of ‘Ready To Hang’ nutritional feeds and feed bags available in Australia.



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Category 7 - Enteral Feeding Pumps

A range of enteral feeding pumps is required to facilitate the delivery of enteral feeds in both a

the hospital environment or as part of a HEN service.

Provision of Pumps

Enteral feeding pumps shall be offered under the following arrangements only: a

(i) outright purchase of pump: for use where the customer owns the enteral feeding

pumps with which the sets are to be used; and

(ii) pump provided ‘free-on-loan’: for use where enteral feeding pumps are being

provided without charge for use with the associated sets.

Where enteral feeding pumps are provided ‘free on loan’: b

(i) they shall remain the property and responsibility of the Respondent;

(ii) the responsibility for service and maintenance shall be retained by the Respondent

(iii) Respondents shall fully detail the arrangement by which pumps are received and

maintained. This includes:

I. the minimum requirements for the hospital to access pumps both at

commencement of the agreement and throughout the life of the agreement;

II. arrangements for pump delivery and acceptance testing;

III. arrangements for preventive inspection/maintenance service and repair including

timing for replacement of defective or ageing equipment and to indicate if these

services are done on-site or off-site;

IV. the process by which enteral feeding pumps are tracked while in active use within

the hospitals and as part of a HEN program;

V. management and reporting of pump inventory provided to the hospitals or health

services;

VI. the responsibility and any costs where pumps are inadvertently damaged or lost.

This should take into account the age of the pump and depreciation in value

across the life of the contact; and

VII. provision of essential accessories i.e. external power supplies and pole clamps.

For all enteral feeding pumps offered, Respondents shall provide the following information in c

the Product Description on the Tender Response Worksheet:

(i) brand name;

(ii) the overall physical dimensions in centimetres;

(iii) the gross mass including battery in kg;

(iv) the net mass excluding charger (where present) in kg; and

(v) GMDNS (Global Medical Device Nomenclature System) preferred term.

For all enteral feeding pumps offered, Respondents shall provide the following information in d

the Product Description on the Tender Response Worksheet:

(i) the ambient operating temperature range;

(ii) the maximum operating altitude;

(iii) is the enteral feed pump and accessories hyperbaric approved from the manufacturer

to withstand elevated atmospheric pressure to at least 2.8 ATA absolute;

(iv) the type of pumping mechanism e.g. peristaltic, piston;



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(v) the minimum and maximum flow rate for continuous feed indicating the percentage of

accuracy of the pump based on industry standard feed of 1.0 Kcal per millilitre;

specifying what fluid and viscosities the flow rate is based on;

(vi) if the pump is recommended for ambulatory use;

(vii) if the positioning of the pump in other than an upright position, adversely affects the

capacity and accuracy of the pumping mechanism;

(viii) any known contraindications to use;

(ix) the recommended useful life of the enteral feeding pump, as suggested by the

manufacturer; and

(x) Pole Clamp – integral/detachable (if detachable does it require a tool to unlock).

Power Supply

All enteral feeding pumps shall be both battery and mains powered. a

Mains Powered

Enteral feeding pumps shall comply with the requirements of this specification when b

operated within the power supply range of 240 volts +/- 10%, 50Hz.

The power supply system shall be immune to the effects of common power surges and c

power fluctuations.

External power supplies that fit squarely and firmly in a typical power outlet and mid-length d

style power supplies may be used where the weight does not exceed 300 grams. External

power supplies must isolate extra low voltage and incorporate over temperature and short

circuit protection.

External power supplies and power supply cables that are faulty or damaged shall be e

replaced at no cost to health services. Faulty cables includes those cables which have

intermittent loss of power.

Battery Powered

Enteral feeding pumps shall incorporate: f

(i) a battery system that will maintain power to fully operate the pump in the event of the

removal of the mains supply; and

(ii) an indicator that clearly identifies that the pump is running on battery power.

The battery shall be continuously charged from a mains power supply, even if the power g

control switch of the pump is turned off.

A clear visual indication and audible alarm must be given to warn that the battery power is h

nearly exhausted.

Enteral feeding pumps shall start up and continue to operate accurately on mains power i

despite a fully discharged battery is being connected.

Tenders shall provide the following information on the Tender Response Worksheet: j

(i) the life expectancy of the battery;

(ii) the time required (in minutes) to fully charge a fully discharged battery;

(iii) the period of time (in hours) for which a fully charged battery can operate a pump

when set at a rate of 100-125 millilitres per hour; and

(iv) the time duration that the pump will continue to run after battery low alarm first

sounds.



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the minimum battery life (in hours); preference will be given to pumps that can operate as k

described in Category 7 – Battery Powered clause “j” above for a minimum of six (6) hours.

Construction Quality

All pumps shall: a

(i) be of robust construction from durable materials;

(ii) be finished to a high quality, commercial finish;

(iii) have no rough or sharp edges;

(iv) have switches, knobs, and other controls that are designed for conditions of heavy

use; and

(v) have an attachment point for a pole clamp (if not fixed).

Performance

During the delivery cycle, the flow rate shall remain as continuous as possible. a

Enteral feeding pumps should have: b

(i) an accuracy of selected rate and volume of ±10%;

(ii) a maximum flow rate of at least 300ml/hr; and

(iii) a flow rate range of 1 ml/hr to at least 50 ml/hr in 1ml increments and thereafter, in

increments of up to 5 ml.

Ease of Use

Enteral feeding pumps should be easy to set up, prime and be simple to use; c

Controls shall be easy to set and logically arranged; d

Labels and displays shall clearly and concisely identify the functions of all switches, controls, e

monitors and displays;

The control setting values shall be easy to read and determine; f

The external housing of the pump shall be easy to clean; and g

A brief set of instructions and important precautions shall be permanently and prominently h

displayed on the device.

Displays

Displays shall be easily read at one (1) metre from the pump in day and night time a

conditions.

LCD displays shall have a backlight facility. b

An indicator on the display shall be present that indicates: c

(i) an infusion is in progress;

(ii) the pump is running on battery or mains power; and

(iii) amount of battery life remaining.

Respondents shall advise the parameters displayed by the pump on the Tender Response d

Worksheet. These shall include as a minimum:

(i) infusion rate;

(ii) total volume to be infused; and



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(iii) volume delivered;

Preference may be given if additional parameters are displayed by the pump for example on e

the following:

(i) dose limit;

(ii) intermittent flushing mode; and

(iii) bolus feeding option.

Alarms

Enteral feeding pumps shall have the following clearly audible and visual alarms as a a

minimum:

(i) set dislodgement/free-flow detection;

(ii) empty bag/container/infusion complete detection;

(iii) occlusion alarm; and

(iv) battery depleted/low alarm;

The cause of each alarm condition shall be readily identifiable by the user. b

Respondents shall advise on the Tender Response Worksheet if: c

(i) the volume of the pump alarm is adjustable (must remain sufficient to hear in

presence of moderate ambient noise (65dB).

(ii) the alarm can be switched off; and

(iii) the alarm can be disabled.

Marking Information

Each enteral feeding pump offered shall be marked legibly and permanently with: a

(i) manufacturer’s name or registered trade mark;

(ii) model number or name specific to the particular design;

(iii) equipment serial number;

(iv) supply voltage, frequency and the current or power rating;

(v) fuse type and ratings;

(vi) control function labels, connector function labels;

(vii) hazard warnings (if applicable); and

(viii) electrical safety classifications.

Enteral feeding pumps training requirements

Operator Training

Respondents shall provide the following information in their response. a

(i) full details of the operator training program including the duration and content

Training shall: b

(i) be provided by personnel experienced in training;



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(ii) include all aspects required for safe and effective pump operation including set-up

and operation, trouble-shooting, any safety and emergency procedures, and

equipment cleaning;

(iii) occur on-site at the relevant hospital or health service;

(iv) other care settings including homes and community; and

(v) accommodate all relevant staff over a number of shifts.

Successful Respondents shall ensure that service and/or educational personnel do not c

discuss or suggest other products or devices, other than those products or devices that they

have been requested to support.

Training of Hospital Biomedical Engineers

Respondents shall provide in their response: d

(i) full details, including curriculum and costs, of a recognised and approved

manufacturer’s technical training course on the pump/s offered.

The training courses shall be of a recognised and approved manufacturer’s technical e

training course (both state and national) on the pump/s offered and shall be equal to the

course/s that the manufacturer's biomedical engineering staff is required to undertake.

This training shall include, but not be limited to: f

(i) equipment operation;

(ii) inspection;

(iii) preventative maintenance and calibration;

(iv) trouble-shooting; and

(v) repair.

Respondents shall provide the following information in their response: g

(i) the availability of loan pumps to cover extended repairs; and

(ii) all costs and responsibilities associated with the provision of enteral feed pumps

including spare parts, and specialist tools/equipment.

Software Updates

In the event of a software update, the Respondent shall: a

(i) provide such updates at no cost;

(ii) perform supplementary in-service training at no cost in the event that the software

updates changes the operation or servicing of any equipment;

(iii) operation; and

(iv) inspection.

Service and Parts

Respondents shall provide the following information in their response: a

(i) the details of a full comprehensive service & maintenance contract including all costs;



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(ii) the recommended frequency of preventive inspection/maintenance required to ensure

quality control.

A written report shall be provided to the relevant hospital representative for all services b

undertaken; details of test results must be available to PHS on request.

Respondents shall guarantee the supply of all necessary spare parts, special tools and c

instruments, revised and tested software and all other technical data:

(i) for the duration of any resulting contract; and

(ii) for a minimum of five (5) years from the date that any model of enteral feeding pump

offered is no longer manufactured.

Successful Respondents must notify HPV and Participating Health Services of ‘end of

support’ for all pumps and associated consumables and semi-consumables by the last date

of manufacture. If an upgrade is required to ensure continuing support, the cost of this

upgrade should not be more than 50% of the cost of a new replacement device (if the

upgrade cost exceeds this amount, the device will be considered to be no longer supported).

Where provided, diagnostic software shall: d

(i) be supplied in the appropriate form e.g. compact discs, flash drives, together with one

(1) copy of a user manual for such software;

(ii) not be copy-protected and shall be identical in all aspects with the software used by

the manufacturer’s field service personnel; and

(iii) be the latest updated and tested version available at the time of delivery.

Any sets required for calibration or performance testing of enteral feeding pumps and e

accessories shall be supplied to Health Services at no cost regardless if the pumps are

purchase outright or free-on-loan.

Warranty

Enteral feeding pumps shall have a minimum warranty period of twelve (12) months. a

The Respondent shall provide the following information in their response: b

(i) the period and extent of the warranty period, including all terms and conditions; and

(ii) details of any preventative maintenance to be undertaken at the Respondent’s

expense during the warranty period, including frequency of service and nature of

work.

Operating Manuals

Operator User Manuals

For each type of enteral feeding pump offered, successful Respondents shall provide one a

complete copy of all operator user manuals for retention by hospital or health service based

Biomedical Engineering services.

Operating user manuals shall be in English and shall include but not be limited to: b

(i) the comprehensive operating instructions;



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(ii) all information necessary to operate the equipment in accordance with specifications

and without exceeding safety limits;

(iii) recommended procedures for cleaning, battery charging, etc;

(iv) all error messages and troubleshooting procedures; and

(v) safety requirements and precautions.

Technical Maintenance Manual

For each type of pump offered, successful Respondents shall provide one complete copy of c

all technical maintenance information necessary to carry out preventive

inspection/maintenance and repair. The technical documentation shall contain all details

available to the manufacturer’s service staff including tools required, available spare parts

and costs for retention by hospital or health service based Biomedical Engineering services.

Acceptance Testing

Successful Respondents shall provide the following information in their response: a

(i) an overview of equipment acceptance/performance testing procedures carried out on

pumps prior to delivery to the customer; and

(ii) any requirements and the availability of specialised, pump specific equipment

required for testing the system, for the period of installation and acceptance testing.


The following information shall be readily available for all contract users as hard and a

electronic copy:

(i) service and maintenance information including:

I. location and capability of the repair/service facility;

II. location and availability of spare parts and consumable items and their pricing;

III. the work address, telephone/fax numbers including mobile and e-mail contact, for

service or maintenance; and

IV. the process for handling repairs/equipment breakdown including the guaranteed

response time to a call-out following notification of the problem.



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Category 8 - Nutritional Meal Replacement Products

A range of nutritional meal replacement products is required to meet clinical needs. This a

includes:

(i) for in-patients and as part of the Home Delivery Service;


(iii) a full range of:

I. energy levels; and

II. flavours;

(iv) a full range of liquids, powders, puddings, bars and others which includes:

I. milk and non milk type; and

II. with and without added fibre;

Where the thickness of nutritional meal replacement products has been modified to facilitate b

consumption by patients with swallowing difficulties, Respondents are advised to offer these

products in Category 3 - Thickened Beverages.

Where nutrition meal replacement products are claimed to be nutritionally complete they c

shall provide 100% RDI for a male of 31-50 years of age in a defined volume, as described

in "Nutrient Reference Values for Australia and New Zealand" endorsed by the National

Health and Medical Research Council on 9 September 2005.

Where nutrition meal replacement products are tendered specifically for paediatric use and d

are claimed to be nutritionally complete, they shall provide 100% RDI for a child of 4-8 years

of age in a defined volume, as described in "Nutrient Reference Values for Australia and

New Zealand" as endorsed by the National Health and Medical Research Council on 9

September 2005.

Where nutrition meal replacement products are presented in a powdered form, response e

information regarding nutritional content shall be based on the standard dilution and state

the standard dilution volume in millilitres.

For all nutrition meal replacement products offered, Respondents shall provide the following f

information in the Product Description on the Tender Response Worksheet:

(i) brand name;

(ii) presentation type i.e. ready to drink, powder, concentrate, pudding, bar and others;

(iii) pack type i.e. glass bottle, plastic bottle, plastic wrap, tetrapak, can, plastic cup;

(iv) volume in millilitres; or

(v) weight in grams;

(vi) weight of scoop measure in grams (where applicable); and

(vii) flavour;

For all nutrition meal replacement products offered, Respondents shall provide the following g

information on the Tender Response Worksheet:

(i) kilojoules provided per 100 ml or 100 grams of supplement and per unit;


described in clauses Category 8 - clauses b and c;


(iv) protein content, as a percentage of total energy provided, in grams per Litre and per

unit;



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(v) carbohydrate content, as a percentage of total energy provided, in grams per unit,


(vi) electrolyte content of sodium and potassium in milligrams per litre;

(vii) fibre content, in grams per litre and type of fibre;

(viii) where oral nutrition support products are offered for consumption by patients with

specific medical conditions, list other specific nutrients in milligrams per Litre, required

for the medical condition;

(ix) osmolality, in milliosmoles per kilogram water;

(x) presence or absence of:

I. lactose;

II. gluten.

(xi) presence of FODMAPs, specifically:


II. Inulin;

III. Polyols-sorbitol, Xylitol.

(xii) glycaemic index, where available;

(xiii) whether the product is nutritionally complete;

(xiv) Kosher compliant;

(xv) Halal compliant;

(xvi) suitability for individuals on a vegan diet; and

(xvii) if packaging is resealable.



means:





deficiencies.



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Category 9 - Oral Dispensers

A full range of plastic oral dispensers (syringes) and tip caps is required to meet clinical a

needs. This includes:

(i) a full range of:

I. sizes and volumes e.g. 1-60 millilitres;

II. packaging sizing options e.g. box of 10, single individual packs, bulk packs;

III. clear and coloured plungers and clear and coloured barrels;

IV. non-sterile and sterile.

All oral dispensers shall have: b

(i) a tip configuration that is not compatible with a luer connection i.e. hypodermic needle

or needleless IV access port;

(ii) bold scale graduations for easy visualisation that resist removal.

All Oral dispensers shall not have fractionated teaspoon measurements on the syringe c

barrel as the only scale of measurement.

For each oral dispenser offered, Respondents shall provide the following information in the d


(i) brand name;


(iii) the scale of graduations e.g. 0.1 ml;

(iv) colour of:

I. barrel;

II. plunger.

(v) if oral dispenser is packaged with a tip cap.

(vi) non-sterile and sterile

Oral Dispenser Accessories shall include but not limited to the following: e

(i) tip Caps;

(ii) adaptor caps for medication bottles;

(iii) mixing cannula;

(iv) nasogastic tube adaptors.

For each accessory offered, Respondents shall provide the following information in the f


(i) brand name;

(ii) sizes;

(iii) clear or type of colours;

(iv) Non-sterile and sterile.

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F Appendices

Appendix 1 - Product List

CATEGORY SUBCATEGORY

1 Enteral Formula Products

1.01 < 1 Kcal/mL (<4.2 kJ/ml) Peptide or Amino acid based

1.02 < 1 Kcal/mL (<4.2 kJ/ml) Other

1.03 1 - 1.4 Kcal/mL (4.2 - 5.88 kJ/mL) Standard protein without added fibre

1.04 1 - 1.4 Kcal/mL (4.2 - 5.88 kJ/mL) Standard protein with added fibre

1.05 1 - 1.4 Kcal/mL (4.2 - 5.88 kJ/mL) High protein without added fibre

1.06 1 - 1.4 Kcal/mL (4.2 - 5.88 kJ/mL) High protein with added fibre

1.07 1 - 1.4 Kcal/mL (4.2 - 5.88 kJ/mL) Pediatric without added fibre

1.08 1 - 1.4 Kcal/mL (4.2 - 5.88 kJ/mL) Pediatric with added fibre

1.09 1 - 1.4 Kcal/mL (4.2 - 5.88 kJ/mL) Low sodium

1.10 1 - 1.4 Kcal/mL (4.2 - 5.88 kJ/mL) Low carbohydrate, high protein

1.11 1 - 1.4 Kcal/mL (4.2 - 5.88 kJ/mL) Peptide or Amino acid based

1.12 1 - 1.4 Kcal/mL (4.2 - 5.88 kJ/mL) Other

1.13 1.5 - 1.9Kcal/mL (6.3 - 8.0 kJ/mL ) Standard protein without added fibre

1.14 1.5 - 1.9Kcal/mL (6.3 - 8.0 kJ/mL ) Standard protein with added fibre

1.15 1.5 - 1.9Kcal/mL (6.3 - 8.0 kJ/mL ) High protein without added fibre

1.16 1.5 - 1.9Kcal/mL (6.3 - 8.0 kJ/mL ) High protein with added fibre

1.17 1.5 - 1.9Kcal/mL (6.3 - 8.0 kJ/mL ) Pediatric without added fibre

1.18 1.5 - 1.9Kcal/mL (6.3 - 8.0 kJ/mL ) Pediatric with added fibre

1.19 1.5 - 1.9Kcal/mL (6.3 - 8.0 kJ/mL ) low carbohydrate, high protein

1.20 1.5 - 1.9Kcal/mL (6.3 - 8.0 kJ/mL ) other

1.21 ≥ 2.0 Kcal/mL (≥8.4 kJ/mL ) Standard protein without added fibre

1.22 ≥ 2.0 Kcal/mL (≥8.4 kJ/mL ) Standard protein with added fibre

1.23 ≥ 2.0 Kcal/mL (≥8.4 kJ/mL ) High protein without added fibre

1.24 ≥ 2.0 Kcal/mL (≥8.4 kJ/mL ) High protein with added fibre

1.25 ≥ 2.0 Kcal/mL (≥8.4 kJ/mL ) Modified electrolyte

2 Oral Nutrition 2.01 < 1 Kcal/mL (<4.2 kJ/ml) Milk type without added fibre

Appendices


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Support Products 2.02 < 1 Kcal/mL (<4.2 kJ/ml) Milk-type with added fibre

2.03 < 1 Kcal/mL (<4.2 kJ/ml) Non Milk type without added fibre

2.04 < 1 Kcal/mL (<4.2 kJ/ml) Other

2.05 1 - 1.4 Kcal/mL (4.2 - 5.88 kJ/mL) Milk-type without added fibre

2.06 1 - 1.4 Kcal/mL (4.2 - 5.88 kJ/mL) Milk-type with added fibre

2.07 1 - 1.4 Kcal/mL (4.2 - 5.88 kJ/mL) Non Milk type without added fibre

2.08 1 - 1.4 Kcal/mL (4.2 - 5.88 kJ/mL) Peptide or Amino acid based

2.09 1 - 1.4 Kcal/mL (4.2 - 5.88 kJ/mL) Other

2.10 1.5 - 2 Kcal/mL (6.3 - 8.0 kJ/mL ) Milk-type without added fibre

2.11 1.5 - 2 Kcal/mL (6.3 - 8.0 kJ/mL ) Milk-type with added fibre

2.12 1.5 - 2 Kcal/mL (6.3 - 8.0 kJ/mL ) Non Milk type without added fibre

2.13 1.5 - 2 Kcal/mL (6.3 - 8.0 kJ/mL ) Other

2.14 > 2.0 Kcal/mL (> 8.4 kJ/mL ) Milk-type without added fibre

2.15 > 2.0 Kcal/mL (> 8.4 kJ/mL ) Milk-type with added fibre

3 Thickened Beverages

3.01 Level 150 Fruit Drink/Cordial Base

3.02 Level 150 Fruit Juice Base

3.03 Level 150 Milk-type Base

3.04 Level 150 Tea/Coffee Base

3.05 Level 150 Water











4 Thickened Agents 4.01 Thickening Agents

Appendices


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5 Modular Products 5.01 Glucose Polymers

5.02 Protein Powder

5.03 Fibre Powder

5.04 Fat Emulsions

5.05 Combination Products

6 Enteral Feed Administration Sets, Feeding Bags and Accessories

6.01 Pump-driven administration sets

6.02 Gravity-driven administration sets

6.03 Feeding bags with integral administration sets

6.04 Feeding bags without integral administration sets

6.05 Accessories to facilitate the provision of enteral feed administration

7 Enteral Feeding Pumps

7.01 Enteral Feeding Pumps

8 Nutritional Meal Replacement Products

8.01 Nutritional Bars

8.02 Nutritional Desserts

8.03 Nutritional Shakes

8.04 Nutritional Soups

8.05 Nutritional Products - Others

9 Oral Dispensers 9.01 Oral dispenser (syringes), non-sterile

9.02 Oral dispenser (syringes), sterile

9.03 Oral Dispenser Accessories

Appendices


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Appendix 2 - Standards, Guidelines and Other References

A 2.a Standards

The references to the below standards include any amendments, revisions or consolidations

to those standards.

For each standard listed, Respondents are to ensure the latest publication of each standard

is used.

STANDARD NUMBER STANDARD NAME

Standard 3– Preventing and Controlling Healthcare Associated Infections

National Safety and Quality Health Service Standards NSQHSS) by Australian Commission on Safety and Quality in Health Care (ACSQHC).

ISO 80369-3 Small-bore connectors for liquid and gases in healthcare applications- Part 3: Connectors for enteral applications.

ISO 594-1 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment -- Part 1: General requirements.

ISO 594-2 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment -- Part 2: Lock fittings.

ISO 7886-1 Sterile hypodermic syringes for single use -- Part 1: Syringes for manual use.

ISO 7886-2 Sterile hypodermic syringes for single use -- Part 2: Syringes for use with power-driven syringe pumps.

ISO 7886-4 Sterile hypodermic syringes for single use -- Part 4: Syringes with re-use prevention feature.

ISO 11135 Sterilisation of health care products – Ethylene oxide.

AS/NZS 4187 Cleaning, disinfecting and sterilizing reusable medical and surgical instruments and equipment, and maintenance of associated environments in health care facilities.

AS1079.4 Packaging of items (sterile) for patient care Part 4: Flexible Packaging Systems – for single use in hospitals.

EN11137 Sterilisation of health care product – Radiation.

AS/NZS 3200.1.0:1998 and IEC60601 is an equivalent

Medical Electrical Equipment – General requirements of safety – Parent Standard

AS/NZS 3200.2.24:1999 and IEC60601 is an equivalent

Medical electrical equipment - Particular requirements for safety - Infusion pumps and controllers

AS/NZS 3200.1.2.2005 and IEC60601 is an equivalent

Medical electrical equipment - General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests

A 2.b Legislation

The references to the below legislation include any amendments, revisions or consolidations

to those references.

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(i) Therapeutic Goods (Medical Devices) Regulations 2002;

(ii) Therapeutic Goods Act 1989; and

(iii) any other relevant legislation that is both mandatory and fundamental to the operation

of the eventual contract of Enteral Feeding and Oral Nutrition Support.

A 2.c Guidelines and Other References

The references to the below guidelines include any amendments, revisions or consolidations

to those guidelines:

(i) "Nutrient Reference Values for Australia and New Zealand" endorsed by the National

Health and Medical Research Council on 9 September 2005;

(ii) Australian Standardised Terminology and Definitions for Texture Modified Foods and

Fluids 2007 (Nutrition & Dietetics 2007; 64 (Suppl. 2): S53/S76);

(iii) NHMRC (2010), Australian Guidelines for the Prevention and Control of Infection in

Healthcare, Commonwealth of Australia;

(iv) Therapeutic Goods Administration (1991), Therapeutic Goods Order No. 37: General

Requirements for Labels for Therapeutic Goods;

(v) Therapeutic Goods Administration (2004), Uniform Recall Procedure for Therapeutic

Goods, Commonwealth of Australia;

(vi) Therapeutic Goods Administration (2011), Australian Regulatory Guidelines for

Medical Devices;

(vii) ISO 13485 – Medical Devices Quality Management System. References Table of

Subcategory Definitions; and

(viii) Australian New Zealand Food Standards Code 1.2.9: Legibility Requirements.

Appendices


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Appendix 3 - Reference Table of Subcategory Definitions

NUTRIENT % ENERGY REFERENCE RANGE

Energy Level: <1.0 Kcal/100ml (<4.2kJ/100ml)

Standard Protein, amino acids and peptides 13 – 16 %

With Added Fibre ≥ 8 g/L

Energy Level: 1.0 – 1.4 Kcal/100ml (4.2 – 5.9 kJ/100ml)


Standard Protein, amino acids and peptides (Paediatric) 10 – 13 %

High Protein > 16 %

Low Carbohydrate < 40 %

Low Sodium < 20 mg/L


Energy Level: 1.5 – 1.9 Kcal/100ml (6.3-8.0kJ/100ml)


Standard Protein, amino acids and peptides (Paediatric) 10 – 13 %

High Protein > 18 %

Low Carbohydrate < 40 %


Energy Level: 2 Kcal/100ml or greater (≥8.4 kJ/100ml)


Appendices


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NUTRIENT % ENERGY REFERENCE RANGE

High Protein > 18 %

Low Protein < 10 %

Modified Electrolyte Na < 45 mg/L

K < 40 mg/L

P < 750 mg/L


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