Due: On or before October 16, at 2:00 PM CST

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ADDENDUM

NO.

1 RE:

Pre-Submittal Conference

Due: On or before October 16, 20154 at 2:00 PM CST

NOTICE TO BIDDERS:

A. Receipt of this Addendum shall be acknowledged on the Bid Form.

B. Bidders are required to sign this addendum acknowledging receipt and return a copy by email. Corresponding email for this purpose is Michael Llanas, UHS Purchasing, Contract Specialist, at [email protected]

C. This Addendum is part of the

RFP#

215-09-033-LAB

documents for the above referenced project and shall be incorporated integrally therewith.

D. Each bidder shall make necessary adjustments and submit their proposal with full knowledge of all modifications: clarifications and supplemental data include therein.

Company Name: ________________________________________________________

__________________________________ _________________________________

Vendor Signature Date:

(2)

PRE-SUBMITTAL CONFERENCE

A pre-bid conference and a walk through will be held in the 3

rd

floor Rio Tower, Pathology

Conference Room # E0316 at the University Hospital, located at 4502 Medical Drive, San

Antonio, Texas on Tuesday, September 22, 2015, at 8:30 a.m. Parking is available in the

visitor’s parking garage for a fee. This conference will be each Respondent’s opportunity to

ask representatives of UHS questions and clarify provisions of the RFP if necessary. After

the conference, prospective Respondents may submit written questions to the RFP until 2:00

pm. Central Time on September 25, 2015. UHS will not accept questions after that time.

UHS is not obligated to respond to each question and only responses designated as formal

Addenda to the RFP will be binding. However, if UHS decides to answer questions in

writing, then UHS will post the responses to those questions and answers in the UHS

website. Attendance is not required for the pre-response meeting in order to submit a

response, however it is strongly encouraged.

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ADDENDUM

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2 RE:

Questions and Answers

NOTICE TO BIDDERS: The purpose of Addendum NO. 2 is to provide answers to the questions that were on or before September 25, 2015 as instructed on RFP.

RFP#

215-09-033-LAB

Company Name: ________________________________________________________

__________________________________ _________________________________

(4)

Number Question Response 1 Do you use low-titer A liquid plasma and if not,

would you if there were cost savings? We currently do not collect low-titer A liquid plasma. 2 Do you use accrodose pooled platelets and, if not,

would you if there were cost savings?

We currently do not collect accrodose pooled platelets.

3 If it were financially beneficial to do so would you award separate contracts for the different services No 4

We cannot provide a Worker’s Compensation Insurance Certificate since we are a non-subcriber as allowable in the State of Texas. Is this status acceptable for this RFP?

This is not required for the submission of proposal. However please state that you will be able to

provided this if contract is awarded to your company. Total RBC’s Transfused in 2014 – 15,277

Percentage Breakdown: Data not available. 6 AMEX BIP – who pays the associated fee? UHS does not pay any associated fees.

7 How would you define “sell back” Products collected at UHS on behalf of UHS that are sold back to UHS at a cost.

9

What is your expectation of a management

company? (What does each party provide and may other pertinent detail?)

We would like the vendor to manage the staff for the donor room, supplies and operations.

2014 RBC – 6,405

FFP – 6,776

Single Donor Platelet – 1,257

2014:00:00 RBC-15,277

Single Donor and Irradiated Single Donor Platelets – 2,521

Cryo – 1,403

Thawed plasma – 6,736 Whole Blood Platelets – 215 12 Will the party who is rewarded this contract be

required to continue using DonorLogix? If so, for No 13 Are blood products currently carried on Airlife

medical transport vehicles? Yes

14

If a regulatory agency makes changes to current regulatory requirements and those changes cause increase in the costs for vendor to meet those requirements, would UHS be willing to review fees associated with that part of the contract?

Negotiable

15

Please clarify if this language means that once the vendor is selected that the contract must fully negotiated, executed and signed by both parties within 30 days and is there any leeway with this timeframe?

There is leeway with this time frame.

16 Is a stage implementation of a fully executed

contract acceptable? This is negotiable. How many RBC’s do you transfuse annually and

what is the percentage breakdown by blood type.

How many blood products, by product type, does University Health System collect annually?

The RFP states that University Health transfuses approximately 25,000 blood products annually. How is that 25,000 products broken down by product type (RBC, platelet, FFP, Cryo, etc) 10

5

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Number Question Response 17 Please provide an example of transitional period

clause Page 8 of 21, B # 13 is the Transitional Period Clause. 18 Please provide an example of system contract

terms sheet Not available.

20 Explain expectation for “regular utilization data” Monthly activity reports (Monthly reports of data reflecting work done on UHS’s behalf by the vendor)

21

DonorLogix partnership for telerecruitment – Is a contract in place and if so, what are the terms and the length of contract and is it possible to use the vendors’ telerecruitment process instead of DonorLogix

There is a contract in place which expires on 12/31/15. No

22

It states the Health System may select more than one vendor but one page 16 Selection A, it states the award will not be split among multiple vendors. Clarification please.

Page 16, Section A is striked fromt this RFP. For this RFP, award will not be split among multiple vendors.

2014:00:00 RBC: 6,405

FFP: 6,779

Single Donor Platelets: 1,257 Total donors: 50,060

2014 Registered donors: 3,030 25

What metrics do you use to evaluate the success of Donor Logix and would you please provide the most recent YTD results?

Number of Donors Recruited and the increase in donors recruited. Because this is a 3rd party vendor, we can not share YTD data.

26 Please provide insight on UHS interpretation of co-branding.

The donor room will continue to maintain a UHS presence and face to the community. However, management and ownership will belong to the vendor.

2015:00:00 Single Donor Platelets – 661

RBC – 3,916 FFP – 4,075 28 Is the 200 mile requirement door to door from the

blood center HQ to UHS

The vendor should have a facility within a 200 mile radius

31 Please clarify what is meant by sell-back Products collected at UHS on behalf of UHS that are sold back to UHS at a cost.

32

Will UHS provide all medical oversight of

therapeutic apheresis and therapeutic phlebotomy collections?

Yes 33 Please clarify what the word “delivery” is referring

to….what is being delivered? Delivery of services – to donors and patients 34 If a presentation is scheduled, will the final decision

makers be present at that time? Yes Scope of Work: Of the 25,000 blood products

transfused, how many of each type are collected and manufactured by UHS?

How many donors make up the UHS pool of donors?

Please provide metrics that show YTD production rates?

27 24 23

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Number Question Response 35

After one year, what would a successful partnership look like and what metrics will be used to monitor activity toward success?

That would depend on the proposal accepted – negotiable.

36

What is the decision making time line and based on the timeline, is the implementation date negotiable based on when the decision is made?

Decision wil be made as soon as possible. Timeline depends on factors not known at this time. i.e, number of proposals, quality of proposals, etc.

37

What metrics are currently used to evaluate the performance of the donor room, mobile blood drives, manufacturing and the donor staff, and may we have the recent reports?

Number of Donors, Number of Components, Apheresis Split Rate – we can not provide recent reports as these reports are internal quality documents.

38 Are there same staff to collect and manufacture

components? Yes

39

What quality reports are in place for deviations such as QIR’s/CAPA, product waste, and may we have examples of them?

Data internal and not available. 40 Is any part of the donor qualifications process

automated, and if so, please describe? Not currently – will be with SCC 41 How many unique donors make-up the UHS donor

base? 50,050

42 What are the demographics of the current donor

base such as age groups, gender and blood type? Data not available.

44% - whole blood donations donor room 56%- whole blood donations on mobile drives

2014:00:00 13-Jan 14-Feb 12-Mar 13-Apr 12-May 8-Jun 10-Jul 7-Aug 14-Sep 9-Oct 10-Nov 9-Dec 2014- 915 apheresis donations

Apheresis products collected: SDP - 1257

FFP – 557 RBC – 68 What percentage of whole blood collections occur

in the donor room and on mobile?

By month, how many mobile drives are conducted each month

What type and how many of automated collections are performed in the donor room?

45 44 43

(7)

Number Question Response 46 How many whole blood donations are collected

annually? 2014- 6,607

47 How often does your WB donor give annually? 6 times per year 48 How many platelet donors are collected annually

and what is the average split rate? 2014 – 915 donations average split rate 49% (SDP) 49 How often does your average platelet donor give

platelets? Once every 4 weeks

50 Are concurrent products collected on automation? All components are collected on apheresis instruments

51 Is the cost per unit collected (CPUC) monitored and

if so, will you provide that information? Yes – we will not provide that data 52

Would you be willing to share cost data for the donor room, such as employee cost and donor incentive cost?

Donor Incentive cost per donation - $28.61 (this includes PTO incentive)

54 What is the average cost per donor for your donor

incentive plan? $28.61 (this includes PTO incentive) 55 Do you have required hours/days of operations for

you donor room? No

56

What type of equipment do you own or lease for your donor room, mobile collections, and therapeutic apheresis as well as the age of the equipment?

Attached

57 How many of your donors have been tested for the

HLA antibody? None

58 Do you have a rare donor program? No

59

What are the current staffing levels/number of FTE’s for donor room/mobiles and therapeutic apheresis and do they have any roles or responsibilities outside of the donor room or therapeutic apheresis?

9 FTEs – no outside roles

60 What type of components do you produce from

whole blood collections> Leuk. Reduced Red Blood Cells and FFP 2014 data:

i. Therapeutic plasma exchange - 323 ii.RBC exchange - 1

iii.Leukocyte reduction - 2 iv.Platelet reduction – 0

63 Is it possible to get copies of current SOP’s for

therapeutic apheresis? Not at this time 64 Do you expect blood collected at UHS to be

transfused at UHS? Yes

How many therapeutic apheresis collections and what type of collections are performed annually? How many physicians oversee therapeutic apheresis collections?

2 Attending physicians and 1 Resident rotating every 6 weeks

62 61

(8)

Number Question Response 65 How are medical residents used to support the

donor room and therapeutics?

Fully support therapeutic apheresis and are present for procedures. Used as resource in donor room for donor safety/eligibility questions.

66 Will UHS continue to provide donor incentives to

their employees at their own costs? Negotiable 67

Current UHS collection staff become blood center employees or remain UHS employees managed by blood center?

UHS employees remain – Negotiable

69

For Board approval – what is the approval criteria for board voting to approve RFP? Is 100% approval required or 51% approval required?

A majority vote is required for approval.

70 Who will be providing medical oversight over the

therapeutic apheresis service? UHS/UTHSCSA 71

Therapeutic Apheresis: Is a blood center MD required to be onsite for the duration of the therapeutic apheresis procedure?

With current staff (Laboratory Technologists), yes Therapeutic Apheresis:

Is an LVN or RN preferred for the administration of therapeutic apheresis?

Therapeutic Apheresis:

If medical oversight is with the UHS pathology staff, will they also be managing the nurses?

Therapeutic apheresis:

Regarding billing, will this be a fee for service or will we be required to bill insurance?

Therapeutic phlebotomies: 2014: 282 phlebotomies Average 23 per month

2015 increased to 35 average per month 76 Therapeutic phlebotomies:

77 Who provides medical oversight for therapeutic phlebotomies?

Yes, $15 credit for each replacement donation Approximately 80 per year

79 What % of collections is from whole blood? 88% 80 What % of collections is from automation? 12%

Mon-Wed 8:30-7:00pm Thurs-Fri 7:00-5:00pm

Saturday 8am-12pm Negotiable

Will the current donor room and lab space be

rented to the blood center or will the current donor Negotiable

Regulatory guidelines for performance of therapeutic apheresis should be followed

They will provide medical oversight.

UHS/UTHSCSA Donor gifts – does UHS have a patient replacement

program? If so, what are the program details?

What hours and days of the week is the fixed site open?

How many phlebotomies are performed a year? 75 74 73 72 68 81 78

(9)

Number Question Response 82 What % of fixed site collections is from walk in

donors? Approx. 30%

83 How many mobiles drives per week? 4-Feb

18 mobile locations with drives 6 times per year 2 large with average donations 118 7 medium with average donations 20-44

9 small with average donations 10-19

2014 WB RBC – 6,337

ApherRBC – 68 WB FFP – 6,219 Apher FFP - 557

Single Donor Platelet – 1,257 What is the average drive size (# of procedures) of

each mobile event?

What are annual volumes for self-collected units: RBC? SDP? Cryo? Cryo Pools? WB FFP? Apheresis FFP equivalents? Rec plasma <24 hours (units)? Rec plasma >24 hours (units)?

85 84

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Number Question Response

2014:00:00 RBC-15,277

Single Donor and Irradiated Single Donor Platelets – 2,521

Cryo – 1,403

Thawed plasma – 6,736 Whole Blood Platelets – 215 87 What types of research products are needed? How

many units of each?

Donor Room does not currently collect research products

2014-60 RBC loss due to positive testing

4 Single donor platelet loss due to positive testing 89 What is RBC and SDP outdates (# of units)?

Data not available – this question pertains to transfusion department; not pertaining to donor services

90 What is the expiration date of contract for blood product purchases (with community blood center)?

91

Are there standing orders or volume commitment requirements for purchases with community blood center? If so, what are they?

92

If able to increase self-collection volumes, how will that (what is) impact contract with community blood center?

93 Does local community blood center purchase

excess product? No excess product from Donor Services. 94 Using the formula INSERT HERE what is the current

cost per unit collected? Can not share this information Total donors: 50,060

2014 Registered donors: 3,030 96 How far out have commitments for mobile

collections been made with community partners? Scheduled through December 2015. 97 What is the sq ft of the manufacturing area? 750 sq feet

98 What technology is used for xxxx? Clarify XXX? 100 What BECS (vendor and version) do you currently

use?

Cerner Classic 8.0.2 – Converting to SoftDonor on November 7th

6 for Donor/Apheresis/Therapeutic Phlebotomy 2 recliners for Therapeutic Apheresis

What are the annual volumes transfused: RBC? SDP? Cryo? Cryo Pools? WB FFP? Apheresis FFP equivalents? Rec plasma <24 hours (units)? Rec plasma >24 hours (units)?

What are RBC and SDP testing losses (# of units)?

What is the current size of your donor base? (total registered donors)

What is the sq. ft. of the donor fixed site location? 1665 sq feet How many beds in fixed site location?

95 88 86

102 101

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103 What is the age of mobile coaches? No coaches. Donor van 8 years old used to carry equipment to mobile site.

104 How many beds on each donor mobile coach? N/A

2014 Total Blood Components collected: 14,438 2014 Blood Components projected: 14,700 4 Collection staff

1 Manufacturing Staff 2 Operations/administrative

2 Therapeutic Apheresis/Component processing 107 Is staff dedicated to fixed or mobile collections? Cross trained for both.

1 manufacturing staff – HS diploma with clinical lab experience

2 Component processing – MLS/MLT ASCP certification

109 What are the total/net procedures per FTE? Data not available 110 What are the total RBC+SDP products per FTE? Data not available 111 What is % of staff turnover? 0% in 2014 112 What services does Donor Logix perform for you?

Telerecruitment? Document Review? Telerecruitment 113 What is the effective term of your contract with

Donor Logix? 31-Dec-15

114 What % donor base growth has Donor Logix

achieved during contract term? Data not available 115 What are the donor base growth goals for Donor

Logix? Data not available

116 What is the effective term of your plasma contract? No contract. 117 Are there annual volume requirements for your

plasma contract? If so, what are the requirements? N/A

118 Who currently performs donor testing? Qualtex Laboratories 119 What is the effective term of donor testing

contract?

120 Are there volume commitments in donor testing contract? If so, what are the requirements?

121

What contractual commitments exist (vendor and effective dates) for purchases of blood collection supplies? (bags, kits, snack, etc.)? What are the volume commitments?

We have a contract in place for Blood Bags. Effective date is through November 1, 2015. 480 cases annually.

Qualtex Contract term is from 10/1/2014 through 9/30/2017. Volume commmitments are not available.

What is the net annual/YTD cells collected vs. net annual/YTD cells forecast?

What are total FTE’s for: collection staff?

Manufacturing staff? Operations/administrative staff? Other staff?

What are credentials of staff in manufacturing/component lab? 108

106 105

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Number Question Response 122 What type of (if any) automation is used in the

collection of blood and blood products?

Trima Accel collection instruments used for apheresis products. Hemoflow 400 instruments used for WB collection. SDP Apheresis FFP Apheresis RBC LR RBC (WB) FFP (WB) Recovered plasma (WB) Autologous WB 124

Do you require/manufacture boutique products, if so what volume? Washed RBC, volume reduced platelets, CPDA-1, pediatric transfusable plasma, aliquot RBC, HLA products, antigen screened RBC

Data not available – products purchased from blood supplier

125 What (if any) immune hematology reference

testing is performed? None from Donor Services 126 What technology is used to perform hematology

testing? Sysmex XE 5000

127 What technology is used for bacterial detection? BD BACTEC 128 Do you perform irradiation, if yes what type of

technology do you use? Not in Donor Services

129 Do you perform your own product Quality Control? Residual WBC for WB and Apheresis QC is performed by Qualtex laboratories. All other performed at UH. 130 What is your expectation in regards to staff/MD?

Do they work for BSI or for UHS?

UHS Staff negotiable. MD serves provided by UTHSC/UHS Donor Staff: (1) Lead Technologist (1) Donor Coordinator (5) Technicians (2) Technologists

Of these positions, Job Duties include: (4) Collection staff

(1) Manufacturing Staff (2) Operations/administrative

(2) Therapeutic Apheresis/Component processing Support Services

Hospital Quality/Risk Management Hospital Administration

Pathology Administration

UT Medical Directors/Pathologists What products do you currently manufacture?

SDP, WB derived platelets, recovered plasma, transfusable plasma (FP24, plasma from

automation?), double RBC, WB, LR or non-LR RBC, cryo pooled cryo etc

Structure: Please provide a detailed org chart that includes a) the staff involved in each component of services that are part of the RFP (donor center, manufacturing, THAP, etc) and the current support services, such as quality or hospital risk

management, that support them (eg where do PDI's go). What are the specific functions of each staff or position identified?

131 123

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132

Data: What kind of data do you currently measure for the services lines involved in the RFP?

Howoften do you measure and review them? Who do you report them to (including hospital and administrative committees and leadership)? Will that kind of data be readily available in a

transparent format for ongoing operations to the successful bidder? What type of data do you expect to come from the successful bidder?

Internal quality data – not able to provide

133

Do we have permission to partner/seek subcontractors for therapeutic apheris and/or therapeutic phlebotomy services?

(14)

Number Question Response What type of apheresis procedures? What is the

average number of procedures per year (for each)? 2014 data:

i. Therapeutic plasma exchange i. Therapeutic plasma exchange - 323 ii. RBC exchange ii.RBC exchange - 1

iii. Leukocyte reduction iii.Leukocyte reduction - 2

iv. LDL apheresis iv.LDL apheresis – Do not perform v. Platelet reduction v.Platelet reduction - 0

vi. MNC collection vi.MNC collection – Do not perform vii. PBSC collection vii.PBSC collection – Do not perform

TPE increase:

Average per month 2014 – 23 Average per month 2015 – 35 135

Are therapeutic apheresis or therapeutic

phlebotomy procedures all in patient? Outpatient? Or a mix of both?

Mix of both. 136 What is the role of the blood center physician

overseeing the program? Medical oversight. Donor/Patient safety. 137 Are the patients managed by ordering physician

and the nurses are just there to do the procedure?

Procedures performed by MLS staff. Physician must be present for entire procedure.

138 What is the estimated number of stat orders for

procedures? 1 per month.

139 Who triages requests when the service is

overloaded? Medical staff.

140 What are the credentials of staff working on the Technologists – MLS/MLT ASCP certification 141 How many nurses/staff are working now? How

many full time? Part time? 2 Therapeutic Apheresis FT technologists 142 Is the staff salaried or hourly employee and

estimate of overtime if hourly? Hourly Overtime 1% 134

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ADDENDUM

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3 RE:

Due date has been extended to 10/23/2015

NOTICE TO BIDDERS: The purpose of Addendum NO. 3 is to extend the due date for bids/offers to October 23, 2015.

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Company Name: ________________________________________________________

__________________________________ _________________________________

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ADDENDUM

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Due date has been extended to 10/23/2015

NOTICE TO BIDDERS: The purpose of Addendum NO. 4 is to provide the balance of the questions/answers and information requested on or before September 25, 2015.

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Company Name: ________________________________________________________

__________________________________ _________________________________

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1 What is your definition of " non-stck" items? N/A

2 Explain acess to non-stock items N/A

3 Will UHS provide Marketing budget for co-_branding? No

4

Under Organization, it states" What are your statistics".Please clarify what statistics you are requiring to review?

How many donors collected in a month( by product type)? What areas are they collected in? Donor Criteria?

6 Please provide a schematic of _{manufacturing/component lab.} Attached

Attached What is your Donor incentive plan?

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ADDENDUM

NO.

5 RE:

Due date has been extended to 11/6/2015

Due: On or before November 6, 2015 at 2:00 PM CST

NOTICE TO BIDDERS: The purpose of Addendum NO. 5 is to extend the date for bids/offers to November 6, 2015.

RFP#

215-09-033-LAB

Company Name: ________________________________________________________

__________________________________ _________________________________