36C25020A0043-003.pdf

VHAPM Part 808.405 6 Limiting Sources Attachment 2: Request for Limited Sources Justification Format >SAT

VHAPM Part 808.405 6 Limiting Sources Page 1 of 8 Original Date: 08/30/2017 Revision 01 Eff Date: 04/23/2018

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405 6

Acquisition Plan Action ID: 36C250 19 AP 6399

1. Contracting Activity: Department of Veterans Affairs, VISN 10, Network 10 Contracting Office, and the Roudebush VA Medical Center, 1481 W. 10th Street, Indianapolis, IN 46202.

2237: See below:

Site 2237 Number

VAMC Ann Arbor 506 20 1 1030 0012 Toledo Outpatient Clinic 506 20 1 1098 0006 VAMC Battle Creek 515 20 2 020 0010 Wyoming VA Clinic 515 20 2 110 0005 VAMC Detroit 553 20 1 058 0019 VAMC Indianapolis 583 20 1 054 0017 VAMC Northern Indiana Healthcare System – Fort Wayne 610 20 1 087 0002 VAMC Northern Indiana Healthcare System – Marion 610 20 1 087 0001 St Joseph County (Mishawaka) CBOC 610 20 1 087 0023 VAMC Saginaw 655 20 2 039 0012

2. Description of Action: This acquisition is conducted under the authority of the Multiple Award Schedule Program (41 U.S.C. 251 and 40 U.S.C. 501). This acquisition is for Werfen USA to provide coagulation cost per reportable result (CPRR) services and products for direct care of patients and veteran clients at the facilities identified in Section 1. This will be awarded as a new requirement.

Order against: FSS Contract Number: __V797D 30108_____________________

Name of Proposed Contractor: Werfen USA LLC

Street Address: 180 Hartwell Road

City, State, Zip: Bedford, MA 01730 2443

Phone: 800 955 9525

VHAPM Part 808.405 6 Limiting Sources Page 2 of 8 Original Date: 08/30/2017 Revision 01 Eff Date: 04/23/2018

3. Description of Supplies or Services:

The estimated value of the proposed action is $1,668,750.85 for 3 years. Period of performance will be 2/1/2020 through 1/31/2023.

With this multi site action, the government is seeking a base plus 2 option year BPA to replace the current BPA VA251 14 A 0040. The contractor, Werfen USA, will provide coagulation cost per reportable result (CPRR) services and products for direct care of patients and veteran clients at the facilities identified in Section 1.

The CPRR rate will include updated testing equipment that enables all sites to conduct current PT (Prothrombin Time), PTT (Partial Prothrombin Time) and Fibrinogen (FIB) CPRR testing and additional Heparin and D Dimer assays now performed manually. Coagulation analyzer equipment (models ACL TOP 500 and smaller) at each site has been in use in excess of 10 years and is in need of replacement due to fair/wear/tear (FWT) usage and FDA approved technological improvements.

The PT, PTT and Fibrinogen tests are used for pre surgical and post surgical screening, therapeutic monitoring of anticoagulants, and in the evaluation of bleeding disorders. Anti Xa is used exclusively in the monitoring of Heparin (anticoagulant). The D Dimer assay is used in conjunction with the clinical pretest probability assessment to exclude Venous Thromboembolism, Deep Venous Thrombosis, and Pulmonary embolism as well as a screening test for DIC (Disseminated Intravascular Coagulation).

Volumes for tests and assays are included in the IGCE. The annual costs of each facility’s CPRR and assays are:

Annual Price 173,953.34$ 13,236.65$ 15,298.70$ 6,254.00$

96,122.23$ 193,873.95$ 20,159.81$ 5,461.70$ 1,106.25$

30,783.65$

Total 556,250.28$

Roudebush VAMC CPPR and Assaysy Wayne VAMC CPPR and Assaysy Marion VAMC CPPR and Assaysy Joseph CBOC CPPR and Assays Saginaw VAMC CPPR and Assays

Coagulation Facility Costs Ann Arbor VAMC CPPR and Assays Toledo CBOC CPPR and Assays Battle Creek VAMC CPPR and Assays Wyoming VA Clinic CPPR and Assays Detroit VAMC CPPR and Assays

VHABACDeweyB Highlight

VHABACDeweyB Highlight

VHABACDeweyB Highlight

VHABACDeweyB Highlight

VHABACDeweyB Highlight

VHABACDeweyB Highlight

VHABACDeweyB Highlight

VHABACDeweyB Highlight

VHABACDeweyB Highlight

VHABACDeweyB Highlight

VHABACDeweyB Highlight

VHABACDeweyB Highlight

VHAPM Part 808.405 6 Limiting Sources Page 3 of 8 Original Date: 08/30/2017 Revision 01 Eff Date: 04/23/2018

The total base plus 2 option year BPA estimate is listed below:

(4) IDENTIFY THE AUTHORITY AND SUPPORTING RATIONALE (see 8.405 6(a)(1)(i)(A), (B), and

(C) or 8.405 6(b)), AND IF APPLICABLE, A DEMONSTRATION OF THE PROPOSED

CONTRACTOR’S UNIQUE QUALIFICATIONS TO PROVIDE THE REQUIRED SUPPLY OR SERVICE.

(CHECK ALL THAT APPLY AND COMPLETE)

An urgent and compelling need exists, and following the ordering procedures would result in unacceptable delays.

Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized;

Extensive market research of FSS vendors established that only Werfen USA met all site minimum requirements. Research revealed that other vendors could not meet key values outlined below:

a. The International Sensitivity Index of 1.0 could only be met by Werfen USA. An International Sensitivity Index (ISI) continually close to 1.0 allows the VA to keep testing reference ranges consistent between lot numbers of reagents. Pharmacists utilize anagrams based on laboratory ranges to adjust a patient’s medication. This standardization allows minimal changes to therapeutic ranges. As ISI values drift further away from 1.0, the pharmacist’s adjustments to the anagram become harder to compare from previous results and ensure a patient is properly dosed.

b. System alerts required were on Werfen equipment only. If a warning, error, or alert occurs, the analyzer will emit an audible and visual alarm to notify the technologist of an issue. These alerts, warnings, and errors are user defined and volume controlled under secure settings forcing the technologist to acknowledge the alarm.

These alerts, warnings, and errors messages allow technologists to troubleshoot issues that could otherwise delay patient testing and patient care.

c. Specimen testing can only be auto started by Werfen, versus competitor manual intervention. Werfen allows for continuous loading and unloading of samples and reagents with no system interruption. Specimens can be loaded on the analyzer in a single motion with minimal manual intervention by a technologist. Werfen is the

3 Year Cost Estimate

Base Year $ 556,250.28

OPTION YEAR 1 $ 556,250.28

OPTION YEAR 2 $ 556,250.28

Total $ 1,668,750.85

VHABACDeweyB Highlight

VHABACDeweyB Highlight

VHABACDeweyB Highlight

VHAPM Part 808.405 6 Limiting Sources Page 4 of 8 Original Date: 08/30/2017 Revision 01 Eff Date: 04/23/2018 only company with an auto start feature allowing a technologist to load the analyzer and walk away. The analyzer will automatically start sample analysis or reagent level sensing without additional intervention by the technologist.

d. Reagent stability, either in system or refrigerated, cannot be met by Werfen competitors. Reagents with longer stability both in system and in the refrigerator allows for less manual manipulation by reducing pipetting and reconstitution errors, improving efficiency and more accurate results. With a stability of days rather than hours, waste and unused reagents is eliminated. Longer expiration dates allow for minimal amount of technologist time when reconstitution of reagents and controls.

e. Werfen is the only vendor that does not require additional consumables to utilize reagents and controls. No additional stirring rods, condenser caps, or inserts are required. Reagents are reconstituted and ran from the original vial. This reduces the risk of contamination and mixing errors due to manual intervention of reagents/controls.

In the interest of economy and efficiency, the new work is a logical follow on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order must not have been previously issued under sole source or limited source procedures.

Items peculiar to one manufacturer:

A patent, copyright or proprietary data limits competition. The proprietary data is: (If FAR 8.405 6(a)(2)iii before posting. Do not include specific proprietary data.

Only mention the type of equipment, procedure, etc. to show that proprietary supplies or services are being procured.)

These are “direct replacements” parts/components for existing equipment.

The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing. Describe the equipment/function you have now and how the new item/service must coordinate, connect, or interface with the existing system.

(5) DESCRIBE WHY YOU BELIEVE THE ORDER REPRESENTS THE BEST VALUE CONSISTENT WITH

FAR 8.404(d) TO AID THE CONTRACTING OFFICER IN MAKING THIS BEST VALUE

DETERMINATION:

Extensive market research of FSS vendors established that only Werfen USA met all site minimum requirements. Details described in paragraph 4. In addition, changing vendors for this highly specialized testing incurs an inopportune in depth validation of both new equipment and reagents, a change in and re writing of procedures and training of technologists. This is counterproductive, expensive, and directly affects patient care.

VHAPM Part 808.405 6 Limiting Sources Page 5 of 8 Original Date: 08/30/2017 Revision 01 Eff Date: 04/23/2018

Werfen USA has not changed its’ cost per test rate in over 10 years, while maintaining commendable service, maintenance and technical support. This BPA will be awarded against a VA National Acquisition Contract (NAC). Per FAR 8.404(d), all FSS pricing was previously negotiated and determined to be fair and reasonable. For the reasons described in paragraphs 4 and 5, establishing a BPA with Werfen USA represents the best value to the Government.

(6) DESCRIBE THE MARKET RESEARCH CONDUCTED AMONG SCHEDULE HOLDERS AND THE

RESULTS OR A STATEMENT OF THE REASON MARKET RESEARCHWAS NOT CONDUCTED:

VIP searched with NAICS code 325413 and keyword “COAGULATION” and received 0 results.

Therefore; the VA Rule of Two cannot be met. Market Research was conducted, and three large businesses were located that could possibly provide the requirement. There are no additional FSS vendors that can provide the requirement. Stago, Siemens and Werfen USA were reviewed for capability. The findings are listed below:

Stago:

Reagents cannot be removed while the analyzer is running even if not in use. ISI value was 1.3.

Requirement is 1.0. There are no audible alarms for specimen alerts and the alarm button is on the front of the analyzer and can easily be turned off. No audible alarm for missing reagents.

Each specimen must be manually scanned before placing on analyzer. Unable to detect reagent levels for number of tests available. Reagent stability is only 48 hours for PT and 24 hours for PTT on board. Weekly maintenance is 20 30 minutes. Requires stirring rods for some reagents.

Package inserts require centrifugation of specimens for 15 minutes and states a CT AD tube for PTT. If package insert is not followed, must be validated by lab. Reducer is required to reduce humidity and evaporation in reagents.

Siemens:

Does not allow the removal of reagents not in use while the analyzer is testing patient samples.

ISI values can be from 0.9 1.7. There is no auto start of patient sampling once specimens are loaded. A “start” button must be initiated. Cuvettes are poured into a hopper. PT and PTT are stable on board for 72 hours. The D dimer reagents and Quality Controls package inserts state to run them in sample cups.

Werfen USA:

Met our minimal requirements to perform the best patient testing in a timely efficient manner with potential to increase efficiency with various system connections. ISI values between 0.9

1.0. Ability to remove reagents not in use while the analyzer is running patient samples. PT and PTT reagents are stable on board for 10 days. Volume/available tests detection of reagents. Audible alerts for instrument, reagent, and specimens. Auto start of specimen testing once placed on the analyzer. No intervention required to start patient sample testing.

No manipulation or addition of caps, vials, reducers, or transfer of reagents/controls to place on analyzer. Able to detect a Short Sample/QNS of patient samples.

VHAPM Part 808.405 6 Limiting Sources Page 6 of 8 Original Date: 08/30/2017 Revision 01 Eff Date: 04/23/2018

Extensive market research of FSS vendors established that only Werfen USA met all site minimum requirements.

In summary, research revealed that other vendors could not meet key values, process more tests per batch, provide reagents having a longer shelf life to reduce costs, required more technologist intervention and more staff maintenance. Some significant findings were:

The International Sensitivity Index of 1.0 could only be met by Werfen USA.

System alerts required were on Werfen equipment only.

Specimen testing could only be auto started by Werfen, versus competitor manual intervention.

Reagent stability, either in system or refrigerated, could not be met by Werfen competitors.

Werfen is the only vendor that does not require additional consumables to utilize reagents and controls.

(7) ANY OTHER FACTS SUPPORTING THE JUSTIFICATION: None.

(8) A STATEMENT OF THE ACTIONS, IF ANY, THE AGENCY MAY TAKE TO REMOVE OR

OVERCOME ANY BARRIERS THAT LED TO THE RESTRICTED CONSIDERATION BEFORE ANY

SUBSEQUENT ACQUISITION FOR THE SUPPLIES OR SERVICES IS MADE:

Prior to any future acquisition for this equipment/services, market research will be conducted to identify potential sources. Should the market research result in other sources which can satisfy the requirements, those sources will be considered.

(9) REQUIREMENTS CERTIFICATION: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge. I understand that processing of this limited sources justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4. (This signature is the requestor’s supervisor, fund control point official, chief of service or someone with responsibility and accountability.)

Evanne E. Cuculick 306054 Digitally signed by Evanne E. Cuculick 306054

Date: 2019.10.23 16:54:16 -04'00'