Page 1 of 7 ADDENDUM NO. 2. September 19, Provision of Blood Glucose Monitors and Consumables RFP # H General

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1 ADDENDUM NO. 2 September 19, 2017 Provision of Blood Glucose Monitors and Consumables RFP # H General This addendum revises RFP documents. This addendum is issued to respondents of record prior to execution of contract, and forms a part of contract documents and modifies previously issued documents. Insofar as previously issued contract documents are inconsistent with modifications indicated by this addendum, modifications indicated by this addendum shall govern. Where any part of the contract documents are modified by this addendum, all unaltered provisions shall remain in effect. 2. Addendum Acknowledgement Form Acknowledge receipt of this addendum in the space provided on the Addendum Acknowledgement Form. Proposers must include the signed form with their response. Failure to do so will subject Proposers to disqualification. 3. Changes and Clarifications a. Responses to Vendor Questions are provided below. 4. Attachments NEXT PAGE a. None Page 1 of 7

2 1 4.7 Required Standards Why is this type of packaging required? The product must conform to the specifications of the current legal and official standards 2 5 Scope If I'm understanding correctly- health professionals are using finger puncture blood glucose monitors at the bed side? Does that mean they are manually entering the BG data into the EMR? 3 5 Scope Is a cellular connection within the blood glucose monitor sufficient enough for automatic uploads as opposed to a wireless connection? 4 5 Scope In our model, the BG data is uploaded automatically. Is it a necessary requirement to have a desktop for downloading BG data? 5 5 Scope Is it a requirement that the contractor not only provide blood glucose monitors, but CGM devices too? 6 5 Scope When you mention maintenance of monitors and data collection devices both corrective and preventative, you're speaking specifically about the monitors correct? Not that the monitors need to be provided for members that need corrective diabetes (adjusting BG values) and preventing diabetes (prediabetes). It is related ONLY to monitor maintenance - corrective and preventative measures of maintenance? Middle ware RALS wireless network. Data is entered through middleware downloaders are used as back up. Wireless connection is used at CCHHS facilities. Cellular connections are not supported at this time? This is CGM and patient home meter results, in case computers are needed for Provision of institutional CGMs by vendors is part of this RFP. Provision of individual CGMs is optional yes Equipment Quantities 8 6.B Home Glucose Meter What is the difference between the quantity of glucose monitors and the downloaders? Our product is one in the same. The monitor is an automatic uploader via cellular connection. 30,000-40,000 need glucose meters but how many would be ordered for this group? Not all of them will use them. Not all of them need a new course of management. What is the anticipated number of users expected to be delivered home glucose meters of this number that NEED them? Some sites require downloaders. When the system is down we can use downloaders. We do not allow cellular connections within our facilities. Cellular connections might be ok for patient meters connection from home. We encourage patients with diabetes to monitor their blood glucose. At least patients treated with insulin need to monitor the glucose. This will be about 50% of patients. The meters are at no cost to CCHHS. If the ratio strips/meter is higher than 450 (current contract) and suggest to lower to 300 as was in previous contract. We never violated this ratio before and did not need to pay for meters during the contract period. The change in meters will be gradual and will span probably over more than a year. Page 2 of 7

3 9 6.B Home Glucose Meter Can the physician just place the order electronically and then the contractor deliver them to the patient? Providing the meters by the clinical sites allow the nurses to teach patient how to use them and to teach them the survival skills related to blood glucose levels the meter are generating. This has been meters working well so far for many years C Computers is this a requirement even for contractors that don t use a download system? Bed-side monitors Regarding the lockout system- is this for all monitors or just bed side monitors? The contractors has to show how the data could be downloaded from patient home monitors and CGM without the computer. Bed side Outpatient pharmacy Outpatient pharmacy Patients with existing meters shall be converted to new meters at no cost at no cost to who? All newly diagnosed patients will be presented a meter at no additional cost. How do we project for an anticipated number of newly diagnosed patients? Are patients solely responsible to cover strip costs after the initial allotment is over? As above, at no cost to CCHHS since for the vendor it is a low cost item and is calculated against the strips used (high cost item). Clinic. See above, does not matter really if newly diagnosed or not. How to cover the strip cost? This is a great question that in my view should be addressed Do you want shipping centralized or decentralized to the Outpatient Clinics? Only 6 locations are listed Would you clarify expiration dates for Hospital glucose strips, Home meters strips and CGM? CGM will not meet 12 month minimum required in RFP. CGM minimum is 4 months expiration date, and 9 months from date of production. Hospital Glucose product for hospital in patient strips and home meters minimum 12 month self-life Please clarify the need for raw materials, dissolution times, and bioavailability results recorded for the specification lot number of the samples submitted? Raw materials vs. consumable FDA approved products? Please clarify the need for 3 D barcode? Freestyle Precision Pro offers 1D and 2D. CGM, or home meters no 3D Please clarify requirement for each part, Impatient meters, outpatient meters and CGM Clarify the need for computers for home use blood glucose monitors to download patient meter information? What are the expectations for CGM? Define required statistics? Decentralized. There are 14 offsite clinics Expiration of the glucose strips should be 12 month from date received for Shelf life at room temperature. FDA approved. 2D Requirements are as stated in the RFP. No computers for home use. In case computers are needed for downloading the patient home monitor and CGM Page 3 of 7

4 data when those monitors are brought to clinic Which monitoring device needs a bidirectional integration with Cerner Millennium EMR thru Cloud based services? FSPP has a bi-direction interface. CGM no bi-directional applicable Clarify which devices for plug and play, inpatient, outpatient, CGM? Initial New Product Training and in-servicing will be provided for both in/outpatient training. In the use of home glucose monitors to all inpatients and outpatients. What Availability of in-service education as required - need details, days, specifics that are required? A Please clarify meter totals, as we have 298 FSPP that shipped on last contract C Please clarify, that you are asking for 40 hardware computers with XXXX software or just software? d Please clarify need for 3D barcodes, current format is 1D and 2D. Is this a cable cord for home meters? Please clarify per inpatient, outpatient, and cgm. XXXX provided products (includes software) will be included for entire contract term Do you want fact sheets for products already in use? FreeStyle Precision Pro, Precision Xtra, - Do you need this on CGM? Do you want references for each product? How many per each product? Do we need references for FreeStyle Precision Pro? 31 ADC provides warranty on all of their products. We can provide on all of the products we are proposing. Would this meet your needs? Abbott provides electronic Manuals. Will this meet your need? Do you need these for Freestyle Precision Pro, Precision Xtra, Neo, and Libre Pro? All devices with interface to Cerner preferred CGM could be interfaced by downloading the data to some computer or other device. Outpatient home glucose monitoring. Input training, train the trainer timeframe is over a few weeks. Outpatient Pharmacy. Totals are listed in section 6.1, Equipment Quantities Just software 2D barcodes If any cables required to connect or download the data, those should be provided. It is the expectation that supplies, equipment, and services proposed will be valid for the entire contract term. Yes Yes 3 each Yes however a lemon or breakage clause needs to be included Yes Page 4 of 7

5 Contract shall provide in-service training materials for the duration of the contract on an as needed basis. Please clarify the need for annual in servicing? needed basis CCHHS has requested that we provide 3 references. ADC's RFP response will be proposing several products and may not have 3 references that use all 3 at this time. How many do you want per product proposed? Do you need references for FreeStyle Precision Pro - (currently in use)? Would one reference for each product be ok? We will be answering the questions based on ADC's information, is that sufficient? Could CCHHS be more specific on the question of conflict of interest? Would you grant a two week extension for our bid submission? 38 For the bedside glucometer's feature requirement (chapter g), is the comments needed to be entered through the bedside glucometer or computer? This does not state annual in servicing, it states in-service training materials for the duration of the contract on an as Provide as many as available. As long as it answers our questions Refer to the RFP No Both 39 It is necessary for vendor s bedside glucometer system and home-use meter to be alreadyintegrated with the Cerner s EMR or it will be given a time window for vendor to integrate the system after bid award? 40 For real time data capability (Scope 5.5), does that mean the system need the patient be able to upload their test result at home to Cerner s cloud either through a computer software or mobile app? 41 The middle-ware in the hospital system is RALS Web3. So, does that mean the RALS Web3 s data will go to Cerner s EMR? And for patient to upload their data to Cerner s EMR during their visit in the hospital, does the data also have to go through the RALS Web3? How about the data uploaded by patient at home, does the data have to go through the RALS Web3 as well? Already integrated products are preferred. Contractor should provide the fixed timeline to integrate if not already integrated. Yes. If not interfaced already, please provide the concrete timeline to implement this Not necessarily. They could be directly interfaced to Cerner. 42 For our understanding, the 3D barcode is more of the use in industrial setting where high heat can occur. Therefore, does the 3D barcode refer to the 2D QR 2D QR Page 5 of 7

6 code? Or can an example of a 3D barcode code be given? 43 For FDA clearance on arterial, and neonate samples, does the clinical data alone acceptable (the data passed the FDA standard but not yet approved with a 510K) or it must be approved with 510k? 44 The intended purchase volume for Lancets is 9 million (which is marked in the excel file), what is the unit? Box or pcs? 45 If the vendor is also willing to provide the lacing device of other brand at no cost, would this RFP accept other brand's lancing device? 46 The intended purchase quantity of diabetic supplies for the outpatient pharmacy (which is marked in the excel file), it is referring as per year or throughout the whole contract period? 47 In the RFP, it states that all equipment must conform to UL (patient care0, and/or UL187 9X-Ray), and/or UL1262 (Laboratory) equipment construction and safety standards. Is it sufficient that our equipment conform to IEC instead of UL regulation? 48 What is the best estimation to the yearly consumption of the strips for the bedside glucometer? 49 Does this RFP intend to be awarded as a whole or might be awarded in parts. It is acceptable We are buying our lancets from our distributor- Cardinal From a SCM standpoint that is acceptable, but that should be decided by the clinical staff. Quantities give for a whole contract period. "No, UL standard are required as outlined in the RFP." 300,000 each Depends Page 6 of 7

7 ADDENDUM ACKNOWLEDGEMENT FORM As required by the RFP, Proposers must submit this acknowledgement form with their response. One acknowledgement form per response, listing all addenda, is appropriate. Company Name: Representative s Name: Signature: Date: END OF ADDENDUM Page 7 of 7