Solicitation Package 26Q00184.pdf
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- Solicitation number
- 75H70626Q00184
About this file
This is a Request for Proposal (RFP) and Solicitation for Commercial Items issued by the Indian Health Service for an Indefinite Delivery/Indefinite Quantity (IDIQ) contract to provide FDA-cleared hematology analyzer systems with associated reagents, consumables, training, laboratory information system (LIS) interface, and full-service support across multiple Great Plains Area Indian Health Service (GPA IHS) facilities. The solicitation number is 75H70626Q00184, issued August 31, 2026, with offers due September 18, 2026 at 2:00 PM CT. This is a 100% small business set-aside with firm-fixed cost-per-test (CPT) pricing for a base year plus four optional one-year periods, totaling five years of potential performance.
The contract requires delivery and installation of hematology analyzers to 12 GPA IHS locations across South Dakota and North Dakota (Belcourt, Eagle Butte, Fort Thompson, Standing Rock, Kyle, Lower Brule, McLaughlin, Pine Ridge, Rosebud, Sisseton, Wagner, and Wanblee). The contractor must provide only new equipment and components—no used, refurbished, or remanufactured equipment—accompanied by original equipment manufacturer warranties. Pricing must be uniform across all facilities regardless of location, testing volume, or equipment configuration. The contractor shall provide all-inclusive CPT pricing covering hematology analyzers, reagents, calibrators, quality control materials, consumables, installation, training, preventive maintenance, corrective maintenance, technical support, and temporary replacement equipment when necessary. Service response time requirements are two hours for hospitals and four business hours for clinics, with on-site technician arrival within 24 hours for hospitals and next business day for clinics. The contractor must maintain minimum 95% analyzer uptime monthly for each device. All invoices must be submitted through the Invoice Processing Platform (IPP) in accordance with OMB M-15-19 requirements. The issuance authority is the Aberdeen Area Indian Health Service, with contracting officer Nichole R. Lerew.
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| File | Type | Posted |
|---|---|---|
| Sol_75H70626Q00184_Amd_0001.pdf | ||
| Combined synopsis Total Small Business.pdf |
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Text version
SEE ADDENDUMIS CHECKED
CODE 18a. PAYMENT WILL BE MADE BY
CODE
FACILITYCODE
17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER
OFFEROR
CODE 16. ADMINISTERED BYCODE
X
X
X
334516
SIZE STANDARD:
100.00 % FOR:SET ASIDE:UNRESTRICTED OR159
REQUEST FOR
PROPOSAL
(RFP)
INVITATION
FOR BID (IFB)
10. THIS ACQUISITION ISCODE
REQUEST FOR
QUOTE (RFQ)
14. METHOD OF SOLICITATION
13b. RATING
NORTH AMERICAN INDUSTRY
CLASSIFICATION STANDARD
(NAICS):
SMALL BUSINESS
09/18/2026 1400 CT
08/31/2026
605-945-5427MONA WEINMAN
(No collect calls)
INFORMATION CALL:
FOR SOLICITATION 8. OFFER DUE DATE/LOCAL TIMEb. TELEPHONE NUMBER a. NAME
4. ORDER NUMBER3. AWARD/ 6. SOLICITATION
75H70626Q00184
5. SOLICITATION NUMBER
SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS 1. REQUISITION NUMBER PAGE OF
1 23 OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30
TELEPHONE NO.
17a. CONTRACTOR/
15. DELIVER TO
Aberdeen SD 57401
115 Fourth Ave, SE
Federal Building
9. ISSUED BY
7.
2. CONTRACT NO.
EFFECTIVE DATE
1,000
18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW
ISSUE DATE
DELIVERY FOR FREE ON BOARD
(FOB) DESTINATION UNLESS
BLOCK IS MARKED
11.
SEE SCHEDULEX
12. DISCOUNT TERMS THIS CONTRACT IS A RATED
ORDER UNDER THE DEFENSE
PRIORITIES AND ALLOCATIONS
SYSTEM - DPAS (15 CFR 700)
13a.
SERVICE-DISABLED
VETERAN-OWNED
SMALL BUSINESS
(SDVOSB)
HUBZONE SMALL
BUSINESS
8(A)
Aberdeen Area Indian Health Servic WOMEN-OWNED SMALL
BUSINESS (WOSB)
ECONOMICALLY DISADVANTAGED
WOMEN-OWNED SMALL
BUSINESS (EDWOSB)
Multiple Destinations
24.
AMOUNT
23.
UNIT PRICE
22.
UNIT
21.
QUANTITY
20.
SCHEDULE OF SUPPLIES/SERVICES
19.
ITEM NO.
This acquisition is 100% Small Business set-aside for a Firm-Fixed Cost-Per-Test IDIQ type contract to provide FDA-cleared Hematology analyzers with associated reagents, consumables, training, LIS interface and full-service support for multiple GPAIHS locations. Period of performance one (1) base year plus four (4), one (1) year option periods, for a total potential period of performance of five (5) years, as defined in the
SOW.
(Use Reverse and/or Attach Additional Sheets as Necessary)
HEREIN, IS ACCEPTED AS TO ITEMS:
XX
DATED
NICHOLE R. LEREW
. YOUR OFFER ON SOLICITATION (BLOCK 5),
INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE SET FORTH
COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DELIVER
ARE
ARE
31c. DATE SIGNED
27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA
31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)
30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (Type or print)
ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY ADDITIONAL
SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.
27a. SOLICITATION INCORPORATES BY REFERENCE (FEDERAL ACQUISITION REGULATION) FAR 52.212-1, 52.212-4. FAR 52.212-3
AND 52.212-5 ARE ATTACHED. ADDENDA
26. TOTAL AWARD AMOUNT (For Government Use Only)
OFFER
STANDARD FORM 1449 (REV. 11/2021)
Prescribed by GSA - FAR (48 CFR) 53.212
ARE NOT ATTACHED.
ARE NOT ATTACHED.
AUTHORIZED FOR LOCAL REPRODUCTION
PREVIOUS EDITION IS NOT USABLE
30b. NAME AND TITLE OF SIGNER (Type or print)
30a. SIGNATURE OF OFFEROR/CONTRACTOR
28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN
25. ACCOUNTING AND APPROPRIATION DATA
29. AWARD OF CONTRACT: REFERENCE
32e. MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE
32c. DATE 32b. SIGNATURE OF AUTHORIZED GOVERNMENT REPRESENTATIVE
ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED:
32a. QUANTITY IN COLUMN 21 HAS BEEN
RECEIVED INSPECTED
40. PAID BY39. S/R VOUCHER NUMBER38. S/R ACCOUNT NUMBER
37. CHECK NUMBER
FINALPARTIAL
36. PAYMENT
FINALPARTIAL
35. AMOUNT VERIFIED
CORRECT FOR
34. VOUCHER NUMBER33. SHIP NUMBER
COMPLETE
32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE
42d. TOTAL CONTAINERS42c. DATE REC'D (YY/MM/DD)
42b. RECEIVED AT (Location)
42a. RECEIVED BY (Print)
41c. DATE41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER
41a. I CERTIFY THIS ACCOUNT IS CORRECT AND PROPER FOR PAYMENT
STANDARD FORM 1449 (REV. 11/2021) BACK
24.
AMOUNT
23.
UNIT PRICE
22.
UNIT
21.
QUANTITY
20.
SCHEDULE OF SUPPLIES/SERVICES
19.
ITEM NO.
The contractor is required to fill the order based on the statement of work and quoted price.
The "Unit Price" is an all-inclusive cost. All
"inclusive cost" is defined as including travel, lodging, per diem, fringe benefits, i.e., life insurance, social security, federal, state, and local taxes, plus all other costs pertinent to the performance of this purchase.
Period of Performance: 09/18/2026 to 08/31/2027
1 Base Year installation training and ongoing support of Hematology analyzers and associated equipment required for diagnostic testing at the
Great Plains Area Belcourt
Delivery: 08/31/2027
Delivery Location Code: IHSBELCOURT
IHSBELCOURT
Q.N.B.M.H.C.F
1300 Hospital Road
PO Box 160
Belcourt ND 58316 US
Period of Performance: 09/23/2026 to 08/31/2027
2 Base Year installation training and ongoing
Continued ...
32f. TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE
32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT REPRESENTATIVE
23 2 of
ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
NAME OF OFFEROR OR CONTRACTOR
3 23
CONTINUATION SHEET
REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF
(A) (B) (C) (D) (E) (F)
75H70626Q00184 support of Hematology analyzers and associated equipment required for diagnostic testing at the
Great Plains Area Eagle Butte
Delivery: 08/31/2027
Delivery Location Code: IHSEAGLEBUTTE
IHSEAGLEBUTTE
24276 166th Street
Airport Road
EAGLE BUTTE SD 57625 US
Period of Performance: 09/23/2026 to 08/31/2027
3 Base Year installation training and ongoing support of Hematology analyzers and associated equipment required for diagnostic testing at the
Great Plains Area Fort Thompson
Delivery: 08/31/2027
Delivery Location Code: IHSFTTHOMPSON
IHSFTTHOMPSON
1323 BIA Rt. 4 Box 200
FT THOMPSON SD 57339 US
Period of Performance: 09/23/2026 to 08/31/2027
4 Base Year installation training and ongoing support of Hematology analyzers and associated equipment required for diagnostic testing at the
Great Plains Area Standing Rock
Delivery: 08/31/2027
Delivery Location Code: IHSFTYATES
IHSFTYATES
10 Standing Rock Ave
FT YATES ND 58538 US
Period of Performance: 09/23/2026 to 08/31/2027
5 Base Year installation training and ongoing support of Hematology analyzers and associated equipment required for diagnostic testing at the
Great Plains Area Kyle
Continued ...
NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)
Sponsored by GSA
FAR (48 CFR) 53.110
4 23
CONTINUATION SHEET
REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF
(A) (B) (C) (D) (E) (F)
75H70626Q00184
Delivery: 08/31/2027
Delivery Location Code: IHSKYLE
IHSKYLE
1000 HEALTH CENTER ROAD
PO BOX 540
KYLE SD 57752 US
Period of Performance: 09/23/2026 to 08/31/2027
6 Base Year installation training and ongoing support of Hematology analyzers and associated equipment required for diagnostic testing at the
Great Plains Area Lower Brule
Delivery: 08/31/2027
Delivery Location Code: IHSLOWERBRULE
IHSLOWERBRULE
601 GALL ST
PO BOX 248
LOWER BRULE SD 57548 US
Period of Performance: 09/23/2026 to 08/31/2027
7 Base Year installation training and ongoing support of Hematology analyzers and associated equipment required for diagnostic testing at the
Great Plains Area McLaughlin
Delivery: 08/31/2027
Delivery Location Code: IHSMCLAUGHLIN
IHSMCLAUGHLIN
701 E 6TH ST BOX 879
MCLAUGHLIN SD 57642 US
Period of Performance: 09/23/2026 to 08/31/2027
8 Base Year installation training and ongoing support of Hematology analyzers and associated equipment required for diagnostic testing at the
Great Plains Area Pine Ridge
Delivery: 08/31/2027
Delivery Location Code: IHSPINERIDGE
IHSPINERIDGE
Continued ...
NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)
5 23
CONTINUATION SHEET
REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF
(A) (B) (C) (D) (E) (F)
75H70626Q00184
607 Indian Health Road
E. Hwy 18
PINE RIDGE SD 57770 US
Period of Performance: 09/23/2026 to 08/31/2027
9 Base Year installation training and ongoing support of Hematology analyzers and associated equipment required for diagnostic testing at the
Great Plains Area Rosebud
Delivery: 08/31/2027
Delivery Location Code: IHSROSEBUD
IHSROSEBUD
800 HOSPITAL DR
ROSEBUD SD 57570 US
Period of Performance: 09/23/2026 to 08/31/2027
10 Base Year installation training and ongoing support of Hematology analyzers and associated equipment required for diagnostic testing at the
Great Plains Area Sisseton
Delivery: 08/31/2027
Delivery Location Code: IHSSISSETON
IHSSISSETON
100 LAKE TRAVERSE DRIVE
SISSETON SD 57262 US
Period of Performance: 09/23/2026 to 08/31/2027
11 Base Year installation training and ongoing support of Hematology analyzers and associated equipment required for diagnostic testing at the
Great Plains Area Wagner
Delivery: 08/31/2027
Delivery Location Code: IHSWAGNER
IHSWAGNER
110 WASHINGTON ST
WAGNER SD 57380 US
Period of Performance: 09/23/2026 to 08/31/2027
Continued ...
NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)
6 23
CONTINUATION SHEET
REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF
(A) (B) (C) (D) (E) (F)
75H70626Q00184
12 Base Year installation training and ongoing support of Hematology analyzers and associated equipment required for diagnostic testing at the
Great Plains Area Wanblee
Delivery: 08/31/2027
Delivery Location Code: IHSWANBLEE
IHSWANBLEE
210 1st Street PO Box 290
WANBLEE SD 57577 US
Period of Performance: 09/23/2026 to 08/31/2027
13 OY1 ongoing support of Hematology analyzers and associated equipment required for diagnostic testing at the Great Plains Area Belcourt
(Option Line Item)
08/01/2027
Delivery: 08/31/2028
Delivery Location Code: IHSBELCOURT
IHSBELCOURT
Q.N.B.M.H.C.F
1300 Hospital Road
PO Box 160
Belcourt ND 58316 US
Period of Performance: 09/01/2027 to 08/31/2028
14 OY1 ongoing support of Hematology analyzers and associated equipment required for diagnostic testing at the Great Plains Area Eagle Butte
(Option Line Item)
08/01/2027
Delivery: 08/31/2028
Delivery Location Code: IHSEAGLEBUTTE
IHSEAGLEBUTTE
24276 166th Street
Airport Road
EAGLE BUTTE SD 57625 US
Period of Performance: 09/01/2027 to 08/31/2028
Continued ...
NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)
7 23
CONTINUATION SHEET
REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF
(A) (B) (C) (D) (E) (F)
75H70626Q00184
15 OY1 ongoing support of Hematology analyzers and associated equipment required for diagnostic testing at the Great Plains Area Fort Thompson
(Option Line Item)
08/01/2027
Delivery: 08/31/2028
Delivery Location Code: IHSFTTHOMPSON
IHSFTTHOMPSON
1323 BIA Rt. 4 Box 200
FT THOMPSON SD 57339 US
Period of Performance: 09/01/2027 to 08/31/2028
16 OY1 ongoing support of Hematology analyzers and associated equipment required for diagnostic testing at the Great Plains Area Standing Rock
(Option Line Item)
08/01/2027
Delivery: 08/31/2028
Delivery Location Code: IHSFTYATES
IHSFTYATES
10 Standing Rock Ave
FT YATES ND 58538 US
Period of Performance: 09/01/2027 to 08/31/2028
17 OY1 ongoing support of Hematology analyzers and associated equipment required for diagnostic testing at the Great Plains Area Kyle
(Option Line Item)
08/01/2027
Delivery: 08/31/2028
Delivery Location Code: IHSKYLE
IHSKYLE
1000 HEALTH CENTER ROAD
PO BOX 540
KYLE SD 57752 US
Period of Performance: 09/01/2027 to 08/31/2028
Continued ...
NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)
8 23
CONTINUATION SHEET
REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF
(A) (B) (C) (D) (E) (F)
75H70626Q00184
18 OY1 ongoing support of Hematology analyzers and associated equipment required for diagnostic testing at the Great Plains Area Lower Brule
(Option Line Item)
08/01/2027
Delivery: 08/31/2028
Delivery Location Code: IHSLOWERBRULE
IHSLOWERBRULE
601 GALL ST
PO BOX 248
LOWER BRULE SD 57548 US
Period of Performance: 09/01/2027 to 08/31/2028
19 OY1 ongoing support of Hematology analyzers and associated equipment required for diagnostic testing at the Great Plains Area McLaughlin
(Option Line Item)
08/01/2027
Delivery: 08/31/2028
Delivery Location Code: IHSMCLAUGHLIN
IHSMCLAUGHLIN
701 E 6TH ST BOX 879
MCLAUGHLIN SD 57642 US
Period of Performance: 09/01/2027 to 08/31/2028
20 OY1 ongoing support of Hematology analyzers and associated equipment required for diagnostic testing at the Great Plains Area Pine Ridge
(Option Line Item)
08/01/2027
Delivery: 08/31/2028
Delivery Location Code: IHSPINERIDGE
IHSPINERIDGE
607 Indian Health Road
E. Hwy 18
PINE RIDGE SD 57770 US
Period of Performance: 09/01/2027 to 08/31/2028
Continued ...
NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)
9 23
CONTINUATION SHEET
REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF
(A) (B) (C) (D) (E) (F)
75H70626Q00184
21 OY1 ongoing support of Hematology analyzers and associated equipment required for diagnostic testing at the Great Plains Area Rosebud
(Option Line Item)
08/01/2027
Delivery: 08/31/2028
Delivery Location Code: IHSROSEBUD
IHSROSEBUD
800 HOSPITAL DR
ROSEBUD SD 57570 US
Period of Performance: 09/01/2027 to 08/31/2028
22 OY1 ongoing support of Hematology analyzers and associated equipment required for diagnostic testing at the Great Plains Area Sisseton
(Option Line Item)
08/01/2027
Delivery: 08/31/2028
Delivery Location Code: IHSSISSETON
IHSSISSETON
100 LAKE TRAVERSE DRIVE
SISSETON SD 57262 US
Period of Performance: 09/01/2027 to 08/31/2028
23 OY1 ongoing support of Hematology analyzers and associated equipment required for diagnostic testing at the Great Plains Area Wagner
(Option Line Item)
08/01/2027
Delivery: 08/31/2028
Delivery Location Code: IHSWAGNER
IHSWAGNER
110 WASHINGTON ST
WAGNER SD 57380 US
Period of Performance: 09/01/2027 to 08/31/2028
24 OY1 ongoing support of Hematology analyzers and
Continued ...
NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)
10 23
CONTINUATION SHEET
REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF
(A) (B) (C) (D) (E) (F)
75H70626Q00184 associated equipment required for diagnostic testing at the Great Plains Area Wanblee
(Option Line Item)
08/01/2027
Delivery: 08/31/2028
Delivery Location Code: IHSWANBLEE
IHSWANBLEE
210 1st Street PO Box 290
WANBLEE SD 57577 US
Period of Performance: 09/01/2027 to 08/31/2028
25 OY2 ongoing support of Hematology analyzers and associated equipment required for diagnostic testing at the Great Plains Area Belcourt
(Option Line Item)
08/01/2028
Delivery: 08/31/2029
Delivery Location Code: IHSBELCOURT
IHSBELCOURT
Q.N.B.M.H.C.F
1300 Hospital Road
PO Box 160
Belcourt ND 58316 US
Period of Performance: 09/01/2028 to 08/31/2029
26 OY2 ongoing support of Hematology analyzers and associated equipment required for diagnostic testing at the Great Plains Area Eagle Butte
(Option Line Item)
08/01/2028
Delivery: 08/31/2029
Delivery Location Code: IHSEAGLEBUTTE
IHSEAGLEBUTTE
24276 166th Street
Airport Road
EAGLE BUTTE SD 57625 US
Period of Performance: 09/01/2028 to 08/31/2029
Continued ...
NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)
11 23
CONTINUATION SHEET
REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF
(A) (B) (C) (D) (E) (F)
75H70626Q00184
27 OY2 ongoing support of Hematology analyzers and associated equipment required for diagnostic testing at the Great Plains Area Fort Thompson
(Option Line Item)
08/01/2028
Delivery: 08/31/2029
Delivery Location Code: IHSFTTHOMPSON
IHSFTTHOMPSON
1323 BIA Rt. 4 Box 200
FT THOMPSON SD 57339 US
Period of Performance: 09/01/2028 to 08/31/2029
28 OY2 ongoing support of Hematology analyzers and associated equipment required for diagnostic testing at the Great Plains Area Standing Rock
(Option Line Item)
08/01/2028
Delivery: 08/31/2029
Delivery Location Code: IHSFTYATES
IHSFTYATES
10 Standing Rock Ave
FT YATES ND 58538 US
Period of Performance: 09/01/2028 to 08/31/2029
29 OY2 ongoing support of Hematology analyzers and associated equipment required for diagnostic testing at the Great Plains Area Kyle
(Option Line Item)
08/01/2028
Delivery: 08/31/2029
Delivery Location Code: IHSKYLE
IHSKYLE
1000 HEALTH CENTER ROAD
PO BOX 540
KYLE SD 57752 US
Period of Performance: 09/01/2028 to 08/31/2029
30 OY2 ongoing support of Hematology analyzers and
Continued ...
NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)
12 23
CONTINUATION SHEET
REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF
(A) (B) (C) (D) (E) (F)
75H70626Q00184 associated equipment required for diagnostic testing at the Great Plains Area Lower Brule
(Option Line Item)
08/01/2028
Delivery: 08/31/2029
Delivery Location Code: IHSLOWERBRULE
IHSLOWERBRULE
601 GALL ST
PO BOX 248
LOWER BRULE SD 57548 US
Period of Performance: 09/01/2028 to 08/31/2029
31 OY2 ongoing support of Hematology analyzers and associated equipment required for diagnostic testing at the Great Plains Area McLaughlin
(Option Line Item)
08/01/2028
Delivery: 08/31/2029
Delivery Location Code: IHSMCLAUGHLIN
IHSMCLAUGHLIN
701 E 6TH ST BOX 879
MCLAUGHLIN SD 57642 US
Period of Performance: 09/01/2028 to 08/31/2029
32 OY2 ongoing support of Hematology analyzers and associated equipment required for diagnostic testing at the Great Plains Area Pine Ridge
(Option Line Item)
08/01/2028
Delivery: 08/31/2029
Delivery Location Code: IHSPINERIDGE
IHSPINERIDGE
607 Indian Health Road
E. Hwy 18
PINE RIDGE SD 57770 US
Period of Performance: 09/01/2028 to 08/31/2029
33 OY2 ongoing support of Hematology analyzers and
Continued ...
NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)
13 23
CONTINUATION SHEET
REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF
(A) (B) (C) (D) (E) (F)
75H70626Q00184 associated equipment required for diagnostic testing at the Great Plains Area Rosebud
(Option Line Item)
08/01/2028
Delivery: 08/31/2029
Delivery Location Code: IHSROSEBUD
IHSROSEBUD
800 HOSPITAL DR
ROSEBUD SD 57570 US
Period of Performance: 09/01/2028 to 08/31/2029
34 OY2 ongoing support of Hematology analyzers and associated equipment required for diagnostic testing at the Great Plains Area Sisseton
(Option Line Item)
08/01/2028
Delivery: 08/31/2029
Delivery Location Code: IHSSISSETON
IHSSISSETON
100 LAKE TRAVERSE DRIVE
SISSETON SD 57262 US
Period of Performance: 09/01/2028 to 08/31/2029
35 OY2 ongoing support of Hematology analyzers and associated equipment required for diagnostic testing at the Great Plains Area Wagner
(Option Line Item)
08/01/2028
Delivery: 08/31/2029
Delivery Location Code: IHSWAGNER
IHSWAGNER
110 WASHINGTON ST
WAGNER SD 57380 US
Period of Performance: 09/01/2028 to 08/31/2029
36 OY2 ongoing support of Hematology analyzers and associated equipment required for diagnostic testing at the Great Plains Area Wanblee
Continued ...
NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)
14 23
CONTINUATION SHEET
REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF
(A) (B) (C) (D) (E) (F)
75H70626Q00184
(Option Line Item)
08/01/2028
Delivery: 08/31/2029
Delivery Location Code: IHSWANBLEE
IHSWANBLEE
210 1st Street PO Box 290
WANBLEE SD 57577 US
Period of Performance: 09/01/2028 to 08/31/2029
37 OY3 ongoing support of Hematology analyzers and associated equipment required for diagnostic testing at the Great Plains Area Belcourt
(Option Line Item)
08/01/2029
Delivery: 08/31/2030
Delivery Location Code: IHSBELCOURT
IHSBELCOURT
Q.N.B.M.H.C.F
1300 Hospital Road
PO Box 160
Belcourt ND 58316 US
Period of Performance: 09/01/2029 to 08/31/2030
38 OY3 ongoing support of Hematology analyzers and associated equipment required for diagnostic testing at the Great Plains Area Eagle Butte
(Option Line Item)
08/01/2029
Delivery: 08/31/2030
Delivery Location Code: IHSEAGLEBUTTE
IHSEAGLEBUTTE
24276 166th Street
Airport Road
EAGLE BUTTE SD 57625 US
Period of Performance: 09/01/2029 to 08/31/2030
39 OY3 ongoing support of Hematology analyzers and associated equipment required for diagnostic
Continued ...
NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)
15 23
CONTINUATION SHEET
REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF
(A) (B) (C) (D) (E) (F)
75H70626Q00184 testing at the Great Plains Area Fort Thompson
(Option Line Item)
08/01/2029
Delivery: 08/31/2030
Delivery Location Code: IHSFTTHOMPSON
IHSFTTHOMPSON
1323 BIA Rt. 4 Box 200
FT THOMPSON SD 57339 US
Period of Performance: 09/01/2029 to 08/31/2030
40 OY3 ongoing support of Hematology analyzers and associated equipment required for diagnostic testing at the Great Plains Area Standing Rock
(Option Line Item)
08/01/2029
Delivery: 08/31/2030
Delivery Location Code: IHSFTYATES
IHSFTYATES
10 Standing Rock Ave
FT YATES ND 58538 US
Period of Performance: 09/01/2029 to 08/31/2030
41 OY3 ongoing support of Hematology analyzers and associated equipment required for diagnostic testing at the Great Plains Area Kyle
(Option Line Item)
08/01/2029
Delivery: 08/31/2030
Delivery Location Code: IHSKYLE
IHSKYLE
1000 HEALTH CENTER ROAD
PO BOX 540
KYLE SD 57752 US
Period of Performance: 09/01/2029 to 08/31/2030
42 OY3 ongoing support of Hematology analyzers and associated equipment required for diagnostic testing at the Great Plains Area Lower Brule
Continued ...
NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)
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(A) (B) (C) (D) (E) (F)
75H70626Q00184
(Option Line Item)
08/01/2029
Delivery: 08/31/2030
Delivery Location Code: IHSLOWERBRULE
IHSLOWERBRULE
601 GALL ST
PO BOX 248
LOWER BRULE SD 57548 US
Period of Performance: 09/01/2029 to 08/31/2030
43 OY3 ongoing support of Hematology analyzers and associated equipment required for diagnostic testing at the Great Plains Area McLaughlin
(Option Line Item)
08/01/2029
Delivery: 08/31/2030
Delivery Location Code: IHSMCLAUGHLIN
IHSMCLAUGHLIN
701 E 6TH ST BOX 879
MCLAUGHLIN SD 57642 US
Period of Performance: 09/01/2029 to 08/31/2030
44 OY3 ongoing support of Hematology analyzers and associated equipment required for diagnostic testing at the Great Plains Area Pine Ridge
(Option Line Item)
08/01/2029
Delivery: 08/31/2030
Delivery Location Code: IHSPINERIDGE
IHSPINERIDGE
607 Indian Health Road
E. Hwy 18
PINE RIDGE SD 57770 US
Period of Performance: 09/01/2029 to 08/31/2030
45 OY3 ongoing support of Hematology analyzers and associated equipment required for diagnostic testing at the Great Plains Area Rosebud
Continued ...
NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)
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REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF
(A) (B) (C) (D) (E) (F)
75H70626Q00184
(Option Line Item)
08/01/2029
Delivery: 08/31/2030
Delivery Location Code: IHSROSEBUD
IHSROSEBUD
800 HOSPITAL DR
ROSEBUD SD 57570 US
Period of Performance: 09/01/2029 to 08/31/2030
46 OY3 ongoing support of Hematology analyzers and associated equipment required for diagnostic testing at the Great Plains Area Sisseton
(Option Line Item)
08/01/2029
Delivery: 08/31/2030
Delivery Location Code: IHSSISSETON
IHSSISSETON
100 LAKE TRAVERSE DRIVE
SISSETON SD 57262 US
Period of Performance: 09/01/2029 to 08/31/2030
47 OY3 ongoing support of Hematology analyzers and associated equipment required for diagnostic testing at the Great Plains Area Wagner
(Option Line Item)
08/01/2029
Delivery: 08/31/2030
Delivery Location Code: IHSWAGNER
IHSWAGNER
110 WASHINGTON ST
WAGNER SD 57380 US
Period of Performance: 09/01/2029 to 08/31/2030
48 OY3 ongoing support of Hematology analyzers and associated equipment required for diagnostic testing at the Great Plains Area Wanblee
(Option Line Item)
08/01/2029
Continued ...
NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)
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(A) (B) (C) (D) (E) (F)
75H70626Q00184
Delivery: 08/31/2030
Delivery Location Code: IHSWANBLEE
IHSWANBLEE
210 1st Street PO Box 290
WANBLEE SD 57577 US
Period of Performance: 09/01/2029 to 08/31/2030
49 OY4 ongoing support of Hematology analyzers and associated equipment required for diagnostic testing at the Great Plains Area Belcourt
(Option Line Item)
08/01/2030
Delivery: 08/31/2031
Delivery Location Code: IHSBELCOURT
IHSBELCOURT
Q.N.B.M.H.C.F
1300 Hospital Road
PO Box 160
Belcourt ND 58316 US
Period of Performance: 09/01/2030 to 08/31/2031
50 OY4 ongoing support of Hematology analyzers and associated equipment required for diagnostic testing at the Great Plains Area Eagle Butte
(Option Line Item)
08/01/2030
Delivery: 08/31/2031
Delivery Location Code: IHSEAGLEBUTTE
IHSEAGLEBUTTE
24276 166th Street
Airport Road
EAGLE BUTTE SD 57625 US
Period of Performance: 09/01/2030 to 08/31/2031
51 OY4 ongoing support of Hematology analyzers and associated equipment required for diagnostic testing at the Great Plains Area Fort Thompson
(Option Line Item)
Continued ...
NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)
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REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF
(A) (B) (C) (D) (E) (F)
75H70626Q00184
08/01/2030
Delivery: 08/31/2031
Delivery Location Code: IHSFTTHOMPSON
IHSFTTHOMPSON
1323 BIA Rt. 4 Box 200
FT THOMPSON SD 57339 US
Period of Performance: 09/01/2030 to 08/31/2031
52 OY4 ongoing support of Hematology analyzers and associated equipment required for diagnostic testing at the Great Plains Area Standing Rock
(Option Line Item)
08/01/2030
Delivery: 08/31/2031
Delivery Location Code: IHSFTYATES
IHSFTYATES
10 Standing Rock Ave
FT YATES ND 58538 US
Period of Performance: 09/01/2030 to 08/31/2031
53 OY4 ongoing support of Hematology analyzers and associated equipment required for diagnostic testing at the Great Plains Area Kyle
(Option Line Item)
08/01/2030
Delivery: 08/31/2031
Delivery Location Code: IHSKYLE
IHSKYLE
1000 HEALTH CENTER ROAD
PO BOX 540
KYLE SD 57752 US
Period of Performance: 09/01/2030 to 08/31/2031
54 OY4 ongoing support of Hematology analyzers and associated equipment required for diagnostic testing at the Great Plains Area Lower Brule
(Option Line Item)
08/01/2030
Continued ...
NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)
20 23
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REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF
(A) (B) (C) (D) (E) (F)
75H70626Q00184
Delivery: 08/31/2031
Delivery Location Code: IHSLOWERBRULE
IHSLOWERBRULE
601 GALL ST
PO BOX 248
LOWER BRULE SD 57548 US
Period of Performance: 09/01/2030 to 08/31/2031
55 OY4 ongoing support of Hematology analyzers and associated equipment required for diagnostic testing at the Great Plains Area McLaughlin
(Option Line Item)
08/01/2030
Delivery: 08/31/2031
Delivery Location Code: IHSMCLAUGHLIN
IHSMCLAUGHLIN
701 E 6TH ST BOX 879
MCLAUGHLIN SD 57642 US
Period of Performance: 09/01/2030 to 08/31/2031
56 OY4 ongoing support of Hematology analyzers and associated equipment required for diagnostic testing at the Great Plains Area Pine Ridge
(Option Line Item)
08/01/2030
Delivery: 08/31/2031
Delivery Location Code: IHSPINERIDGE
IHSPINERIDGE
607 Indian Health Road
E. Hwy 18
PINE RIDGE SD 57770 US
Period of Performance: 09/01/2030 to 08/31/2031
57 OY4 ongoing support of Hematology analyzers and associated equipment required for diagnostic testing at the Great Plains Area Rosebud
(Option Line Item)
08/01/2030
Continued ...
NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)
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REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF
(A) (B) (C) (D) (E) (F)
75H70626Q00184
Delivery: 08/31/2031
Delivery Location Code: IHSROSEBUD
IHSROSEBUD
800 HOSPITAL DR
ROSEBUD SD 57570 US
Period of Performance: 09/01/2030 to 08/31/2031
58 OY4 ongoing support of Hematology analyzers and associated equipment required for diagnostic testing at the Great Plains Area Sisseton
(Option Line Item)
08/01/2030
Delivery: 08/31/2031
Delivery Location Code: IHSSISSETON
IHSSISSETON
100 LAKE TRAVERSE DRIVE
SISSETON SD 57262 US
Period of Performance: 09/01/2030 to 08/31/2031
59 OY4 ongoing support of Hematology analyzers and associated equipment required for diagnostic testing at the Great Plains Area Wagner
(Option Line Item)
08/01/2030
Delivery: 08/31/2031
Delivery Location Code: IHSWAGNER
IHSWAGNER
110 WASHINGTON ST
WAGNER SD 57380 US
Period of Performance: 09/01/2030 to 08/31/2031
60 OY4 ongoing support of Hematology analyzers and associated equipment required for diagnostic testing at the Great Plains Area Wanblee
(Option Line Item)
08/01/2030
Delivery: 08/31/2031
Continued ...
NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)
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REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF
(A) (B) (C) (D) (E) (F)
75H70626Q00184
Delivery Location Code: IHSWANBLEE
IHSWANBLEE
210 1st Street PO Box 290
WANBLEE SD 57577 US
Period of Performance: 09/01/2030 to 08/31/2031
The Contractor must provide only new equipment and new parts for the required products described herein; no used, refurbished, or remanufactured equipment or parts shall be provided under any circumstances. Absolutely no Gray Market Goods or
Counterfeit Electronic Parts shall be provided.
Gray Market Goods are defined as genuine, branded goods intentionally or unintentionally sold outside of an authorized sales-territory or by non-authorized dealers in an authorized territory. All equipment shall be accompanied by the Original Equipment Manufacturers (OEMs) warranty. Counterfeit Electronic Parts are defined as unlawful or unauthorized reproduction, substitution, or alteration that has been knowingly mismarked, misidentified, or otherwise misrepresented to be an authentic, unmodified electronic part from the original manufacturer, or a source with the express written authority of the original manufacturer or current design activity, including an authorized aftermarket manufacturer. Unlawful or unauthorized substitution includes used electronic parts represented as new, or the false identification of grade, serial number, lot number, date code, or performance characteristics.
Invoice Processing Platform (IPP)
The Indian Health Service (IHS) is in the process of implementing an electronic invoicing system.
In compliance with the Office of Management and
Budget (OMB) M-15-19 memorandum, Improving
Government Efficiency and Saving Taxpayer Dollars
Through Electronic Invoicing, directing Federal agencies to adopt electronic invoicing as the primary means to disburse payment to vendors.
Invoices submitted under any award resulting from this solicitation will be required to utilize the
Invoice Processing Platform (IPP) in accordance with HHSAR 352.232-71, Electronic Submission and
Processing of Payment Requests.
Continued ...
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IPP is a secure, web-based electronic invoicing system provided by the U.S. Department of the
Treasury's Bureau of the Fiscal Service, in partnership with the Federal Reserve Bank of St.
Louis (FRSTL). Respondents to this solicitation are encouraged to register an account with IPP if they have not already done so. If your organization is already registered to use IPP, you will not be required to re-register- however, we encourage you to make sure your organization and designated IPP user accounts are valid and up to date.
The IPP website address is: https://www.ipp.gov
If you require assistance registering or IPP account access, please contact the IPP Helpdesk at (866) 973-3131 (M-F 8AM to 6PM ET), or
IPPCustomerSupport@fiscal.treasury.gov
Should the contractor feel that use of the IPP would be unduly burdensome, their response to this solicitation should include an explanation of this position for a determination by the contracting officer.
The Government reserves the right to accept or reject supplies or services not conforming in all respects to contract requirements.
NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)
Performance Work Statement (PWS)
Hematology Analyzer Systems and Services Great Plains Area Indian Health Service (GPA IHS)
1. Objective
The Government intends to award a firm-fixed-price (FFP), indefinite-delivery/indefinite-quantity (IDIQ) contract for hematology analyzer systems and associated services.
Individual GPA IHS facilities will place task orders under the resulting contract.
The objective of this contract is to obtain hematology analyzer systems and associated services necessary to support diagnostic laboratory testing at Great Plains Area Indian Health Service (GPA IHS) healthcare facilities.
The Contractor shall provide hematology analyzers, reagents, consumables, installation, training, maintenance, and technical support necessary to ensure reliable hematology testing capability across participating facilities.
Facilities include:
Hospitals
• Pine Ridge Hospital – Pine Ridge, SD
• Rosebud Hospital – Rosebud, SD
• Cheyenne River Health Center – Eagle Butte, SD
• Standing Rock Service Unit – Ft. Yates, ND
• Quentin N. Burdick Memorial Health Care Facility (QNB)– Belcourt, ND
Clinics
• Ft. Thompson Health Center – Ft. Thompson, SD
• Lower Brule Health Center – Lower Brule, SD
• Wagner Health Center – Wagner, SD
• McLaughlin Health Center – McLaughlin, SD
• Woodrow Wilson Keeble Memorial Health Care Center (WWKMHC) – Sisseton, SD
• Kyle Health Center – Kyle, SD
• Wanblee Health Center – Wanblee, SD
Estimated annual testing volumes are provided in Appendix A.
2. Background GPA IHS laboratories require reliable hematology testing systems capable of performing automated complete blood count (CBC) testing with differential reporting.
Systems must support:
• Clinical Laboratory Improvement Amendments (CLIA) compliance
• FDA-cleared diagnostic device
• Laboratory Information System (LIS) connectivity
• Continuous laboratory operations across multiple healthcare facilities
3. Scope of Work The Contractor shall provide a complete hematology diagnostic testing solution including:
1. Hematology analyzers and associated instrumentation
2. Reagents, calibrators, controls, and consumables
3. Installation and configuration of analyzer systems
4. Method verification and validation
5. LIS interface capability if required
6. Training for laboratory personnel
7. Preventive maintenance and repair services
8. Warranty and ongoing technical support
4. Analyzer Functional Requirements The proposed analyzer system shall provide:
• Automated Complete Blood Count (CBC)
• 6-part differential capability
• Immature granulocyte reporting capability
• Abnormal cell flagging capability
• STAT sample processing capability
• Pediatric (microtainer) sampling capability
• Open and/or closed tube sampling capability
• Barcode scanning capability
• Automated reagent management capability
• LIS / HL7 interface capability
• Onboard data storage capability
5. Equivalent Technology The Government does not require any specific manufacturer or proprietary technology.
Offerors may propose any analyzer system that meets or exceeds the performance requirements identified in this
Performance Work Statement.
6. Analyzer Placement and Lifecycle Responsibility The Contractor shall provide all instrumentation required to perform hematology testing under this contract.
The Contractor shall be responsible for delivery, installation, configuration, calibration, maintenance, repair, and replacement of instrumentation as necessary during the contract period.
7. Pre-Installation Site Assessment The Contractor shall conduct a site readiness assessment prior to equipment delivery to verify space, electrical, environmental, and network connectivity requirements.
8. Quality Control Compatibility Analyzer systems shall be capable of operating with commercially available third-party quality-control (QC) materials and shall not require the exclusive use of proprietary QC materials for routine operation.
9. Training Requirements The Contractor shall provide on-site training covering system operation, maintenance procedures, troubleshooting, quality-control procedures, and safety protocols.
10. Maintenance and Service
The Contractor shall provide all preventive maintenance, corrective maintenance, repair services, replacement parts, and technical support necessary to maintain the hematology analyzer systems in proper operating condition throughout the period of performance. Unless otherwise specified, all maintenance and repair services required to maintain the systems shall be provided at no additional cost to the Government.
10.1 Preventive Maintenance
The Contractor shall perform preventive maintenance in accordance with the manufacturer's recommended schedule and procedures. Preventive maintenance shall be coordinated with the applicable facility to minimize disruption to laboratory operations.
The Contractor shall maintain records of all preventive maintenance performed and shall provide such records to the Government upon request.
10.2 Technical Support and Service Requests
The Contractor shall provide telephone and/or remote technical support for troubleshooting and resolution of analyzer problems.
For each service request, the Contractor shall document, at a minimum:
• date and time the service request was received;
• nature of the reported problem;
• date and time technical support was initiated;
• troubleshooting and corrective actions performed;
• date and time a service technician arrived on site, when applicable;
• date and time the analyzer was restored to operational status; and
• replacement or contingency equipment provided, when applicable.
10.3 Service Response Time
The Contractor shall provide timely technical support and on-site service, when required, to diagnose and correct analyzer malfunctions.
Initial Technical Response Time is the elapsed time from the Contractor's receipt of a service request to the initiation of troubleshooting by qualified Contractor technical support personnel.
The Contractor shall meet the following initial technical response requirements:
• Hospitals: Technical response shall occur within two (2) hours of receipt of the service request.
• Clinics: Technical response shall occur within four (4) business hours of receipt of the service request.
The Contractor may use telephone, electronic, or remote technical support to diagnose and resolve the reported problem. If the analyzer cannot be restored to normal operational status through remote troubleshooting and on-site service is required, the Contractor shall dispatch a qualified service technician.
On-Site Response Time is the elapsed time from the determination that on-site service is required to the arrival of a qualified Contractor service technician at the affected facility.
The Contractor shall meet the following on-site response requirements:
• Hospitals: A qualified service technician shall arrive at the affected facility within twenty-four (24) hours after determination that on-site service is required.
• Clinics: A qualified service technician shall arrive at the affected facility no later than the next business day after determination that on-site service is required.
For purposes of this requirement, business hours are the applicable facility's established operating hours as identified in Appendix C.
The Contractor shall document the date and time each service request is received, the date and time technical support is initiated, the determination that on-site service is required, when applicable, and the date and time the service technician arrives at the facility.
10.4 Repair and Restoration
Restoration Time is the elapsed time from the Contractor's receipt of a service request for an inoperable analyzer until the analyzer is restored to normal operational status and available for patient testing.
An analyzer shall be considered restored to operational status when the reported problem has been corrected and the analyzer has successfully completed applicable manufacturer-required operational checks and quality control necessary to resume patient testing.
The Contractor shall meet the following restoration requirements:
• Hospitals: Restore the affected analyzer to operational status within 48 after receipt of the service request.
• Clinics: Restore the affected analyzer to operational status within two (2) business days after receipt of the service request.
If the Contractor cannot restore an analyzer within the required restoration period, the Contractor shall determine, in coordination with the facility, whether a functioning backup analyzer is available and capable of maintaining the facility's required hematology testing capability.
When a functioning backup analyzer is available and capable of supporting required testing, the Contractor shall continue corrective maintenance on the affected analyzer until it is restored to operational status. A temporary replacement analyzer shall not be required solely because the restoration period has been exceeded.
When a functioning backup analyzer is not available, is itself inoperable, or is unable to maintain the facility's required hematology testing capability, the Contractor shall provide, at no additional cost to the Government, a temporary replacement analyzer or other Government-approved contingency solution sufficient to maintain required hematology testing capability until the affected analyzer is restored or permanently replaced.
Any temporary replacement analyzer shall be appropriate for the testing requirements of the affected facility and shall be installed, configured, and made operational by the Contractor, including any verification, quality control, and interface activities required before patient testing.
10.5 Analyzer Uptime
The Contractor shall maintain a minimum 95 percent uptime for each analyzer.
Uptime shall be measured monthly for each analyzer using the following calculation:
Uptime (%) = [Total Required Operating Time − Contractor-Attributable Downtime) ÷ Total Required Operating Time] × 100
For purposes of this requirement:
Total Required Operating Time means the number of hours during the measurement period that the analyzer is required to be available for patient testing based on the applicable facility's established operating hours.
Contractor-Attributable Downtime begins when the Contractor receives notification that an analyzer is unavailable for patient testing due to an equipment malfunction or other condition for which the Contractor is responsible and ends when the analyzer is restored to operational status and available for patient testing.
Scheduled preventive maintenance shall not be counted as Contractor-attributable downtime when the maintenance is performed in accordance with the manufacturer's recommended schedule, is coordinated in advance with the facility, and is completed within the agreed-upon maintenance window.
Downtime resulting solely from Government-caused conditions outside the Contractor's control may be excluded from the uptime calculation when adequately documented and accepted by the Government.
10.6 Failure to Meet Performance Standards
The Contractor shall promptly notify the designated Government representative when it becomes apparent that a response-time, restoration-time, or uptime requirement will not be met.
The Contractor shall document the cause of the failure, actions taken to maintain laboratory testing capability, corrective actions performed, and measures taken to prevent recurrence.
Repeated failure to meet the performance requirements of this section may be documented and addressed by the Contracting Officer in accordance with the terms and conditions of the contract.
11. Performance Standards
• Analyzer uptime: minimum 95%
• Preventive maintenance per manufacturer schedule
• Training provided at installation and upon request
• Compliance with CLIA and FDA requirements
12. Demonstration and Validation The Government reserves the right to request a system demonstration or validation prior to award or final acceptance to verify operational capability.
13. Acceptance Criteria
Government acceptance of each analyzer system shall occur only after the Contractor has completed installation and all applicable acceptance requirements identified below. Acceptance shall be determined separately for each facility and documented by the Laboratory Director or authorized Government representative.
13.1 Installation and Operational Verification
Prior to acceptance, the Contractor shall demonstrate that:
1. The analyzer and all required components have been delivered, installed, and configured in accordance with the manufacturer's specifications and the requirements of this PWS.
2. The analyzer powers on and operates without unresolved error conditions that would prevent routine patient testing.
3. All required accessories, peripherals, barcode scanners, sample handling components, and other equipment required by the applicable facility configuration are installed and operational.
4. Required reagents, calibrators, controls, and consumables necessary to place the analyzer into routine operation have been provided.
5. Calibration and manufacturer-required installation procedures have been successfully completed.
6. Quality control testing has been completed with results meeting the manufacturer's established acceptable ranges and the facility's applicable quality control requirements.
7. The Contractor has completed required method verification activities in coordination with laboratory personnel and provided the resulting documentation to the Government.
8. Where LIS connectivity is required, the analyzer has successfully transmitted and received applicable test information through the approved LIS interface, and the Government has verified accurate transmission of patient identifiers, test orders, results, units, reference ranges, flags, and other applicable data elements.
9. Required staff training has been completed in accordance with the training requirements of this PWS.
10. The analyzer is available and ready for routine patient testing.
13.2 Required Acceptance Documentation
Prior to Government acceptance, the Contractor shall provide, as applicable:
• installation and equipment configuration documentation;
• analyzer model and serial number;
• manufacturer installation and operational qualification documentation;
• calibration records;
• quality control results generated during installation and verification;
• method verification documentation and results;
• LIS/interface testing documentation, when applicable;
• preventive maintenance schedule;
• service and technical support contact information;
• applicable equipment manuals and operating instructions;
• training materials and documentation of completed staff training; and
• warranty and service coverage information.
Documentation may be provided electronically unless otherwise requested by the Government.
13.3 Acceptance Determination
The Laboratory Director or authorized Government representative shall review the completed acceptance requirements and supporting documentation.
Acceptance shall be documented in writing after the Government determines that the analyzer meets the applicable requirements of this PWS and is ready for routine patient testing.
Government use of the analyzer for installation, verification, validation, quality control, training, or other pre-acceptance activities shall not, by itself, constitute acceptance.
13.4 Deficiencies and Correction Procedures
If an analyzer does not satisfy the applicable acceptance requirements, the Government shall identify the deficiency to the Contractor.
The Contractor shall, at no additional cost to the Government, investigate and correct or replace deficient equipment, components, software, interfaces, or other items for which the Contractor is responsible. The Contractor shall repeat any installation, calibration, quality control, verification, or interface testing affected by the correction and provide updated documentation demonstrating successful correction.
For deficiencies that do not affect patient safety, regulatory compliance, accuracy or reliability of test results, or the analyzer's ability to perform required testing, the Contractor shall complete corrective action within five (5) business days after notification by the Government, unless an alternative timeframe is approved by the Contracting Officer or authorized Government representative.
Any deficiency affecting patient safety, regulatory compliance, accuracy or reliability of test results, or the analyzer's ability to perform required testing shall be corrected before Government acceptance and before the analyzer is placed into routine patient testing.
If the Contractor is unable to correct a deficiency within the required timeframe, the Contracting Officer may require replacement of the affected analyzer or take other action authorized by the terms and conditions of the contract.
Correction of a deficiency shall not, by itself, constitute acceptance. The affected analyzer shall remain subject to Government review and written acceptance following completion of all required corrective actions.
13.5 Commencement of Billing
Recurring charges associated with an analyzer, including cost-per-test, reagent rental, or monthly system service charges, as applicable to the awarded pricing structure, shall not begin before the analyzer has been accepted by the Government in accordance with this section and is available for routine patient testing.
For a newly installed analyzer, the effective date for commencement of applicable recurring billing shall be the Government acceptance date documented by the Laboratory Director or authorized Government representative.
The Government shall not be charged for tests, reagents, consumables, or other materials used solely for Contractor installation, calibration, initial quality control, method verification, LIS/interface testing, training, or correction of pre-acceptance deficiencies, unless otherwise expressly provided by the contract.
Government acceptance does not relieve the Contractor of its warranty, maintenance, repair, uptime, or other continuing performance obligations under the contract.
14. Pricing Structure
The Contractor shall provide firm-fixed Cost-Per-Test (CPT) pricing for the hematology testing solution required by this Performance Work Statement.
The Contractor shall propose one uniform CPT for each Government-defined testing unit for each contract year. The applicable contract-year CPT shall apply uniformly to all participating GPA IHS facilities in accordance with Section 15, Aggregated Volume Pricing.
14.1 All-Inclusive Cost-Per-Test
The proposed CPT shall be all-inclusive and shall include all costs necessary to provide, operate, and maintain the hematology testing capability required by this PWS throughout the period of performance.
The CPT shall include, at a minimum:
• all required primary and backup hematology analyzers identified in this PWS;
• delivery, installation, configuration, and equipment placement;
• reagents;
• calibrators;
• manufacturer-required quality control materials;
• consumables and routine operating supplies required for analyzer operation;
• preventive maintenance;
• corrective maintenance and repairs;
• replacement parts;
• technical and remote support;
• service technician labor and travel;
• temporary or replacement analyzers when required by this PWS;
• initial and recurring training required by this PWS;
• analyzer software, licenses, and manufacturer-required software updates;
• equipment replacement necessary to maintain required…
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