AMENDMENT 0001 W81K0023Q0023 SOLICITATION 3.24.2023 RELEASED.pdf

W40M USA HLTH CONTRACTING ACT

REGIONAL HEALTH CONTRACT OFF CENTRAL

POC: SHENECQUA SOARES

36000 DARNELL LOOP

FORT HOOD TX 76544

0011835024

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print)

30-105-04EXCEPTION TO SF 30

APPROVED BY OIRM 11-84

STANDARD FORM 30 (Rev. 10-83) Prescribed by GSA

FAR (48 CFR) 53.243

The purpose of this amendment is to provide answ ers to questons, remove Sickle Cell testing in section 2.4 of the PWS, change 9 minutes or less to no greater than 15 minutes in section 2.4 of the PWS, remove the requirement from section 2.5.1 of the PWS and to extend the offer due date and time from 31 March 2023 at 2:00 pm central standard time to 7 April 2023 at 2:00 pm central standard time.

See Summary of Changes.

1. CONTRACT ID CODE PAGE OF PAGES

1 23

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

16C. DATE SIGNED

BY 24-Mar-2023

16B. UNITED STATES OF AMERICA15C. DATE SIGNED15B. CONTRACTOR/OFFEROR

(Signature of Contracting Officer)(Signature of person authorized to sign)

8. NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and Zip Code) X W81K0023Q0023

X 9B. DATED (SEE ITEM 11)

16-Mar-2023

10B. DATED (SEE ITEM 13)

9A. AMENDMENT OF SOLICITATION NO.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

X The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offer X is extended, is not extended.

Offer must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended by one of the following methods:

(a) By completing Items 8 and 15, and returning 1 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN

REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE

CONTRACT ORDER NO. IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(B).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not, is required to sign this document and return copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

10A. MOD. OF CONTRACT/ORDER NO.

2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO.(If applicable)

6. ISSUED BY

3. EFFECTIVE DATE

24-Mar-2023

CODE

W40M USA HLTH CONTRACTING ACT

REGIONAL HEALTH CONTRACT OFF CENTRAL

2539 GARDEN AVENUE

FT SAM HOUSTON TX 78234-0000

W81K00 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE W81K00

FACILITY CODECODE

EMAIL:TEL:

W81K0023Q0023

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 1449 - CONTINUATION SHEET

SOLICITATION/CONTRACT FORM

The required response date/time has changed from 31-Mar-2023 02:00 PM to 07-Apr-2023 02:00 PM.

The following have been added by full text:

QUESTIONS AND ANSWERS

1. This RFP is stated as "all or none", however one requirement listed is "System capable of performing sickle cell testing as well as Hemoglobin A1C testing." We are unaware of any Chemistry/Immunoassay system that can perform both A1c and Sickle Cell testing. Could this be bid upon separately since we have systems that have the capability of performing both A1c and Sickle Cell testing? In addition, if you are willing to open bidding for autoimmune and infectious disease testing, we have a platform that can be attached to several automation lines.

Response: Sickle cell testing is not needed in chemistry department. Hemoglobin A1c testing is required.

Section 2.4 of the Performance Work Statement has been updated to remove the sickle cell requirement.

2. In order to ensure we have time to create a high-quality response for your review, would Carl R. Darnall AMC consider moving the deadline from March 31st to April 15th?

Response: Solicitation due date has been extended to 2:00 PM Central Standard Time on Friday, 7 April

3. The following assays are typically provided by a third party vendor, please provide current vendors in use:

TCA - Tricyclic Antidepressants screen, Beta Hydroxybuterate, Glucose-6-Phosphate Dehydrogenase (G6PD), Sickle Cell

Response: TCA is provided by Abbott Laboratories (current contractor). Beta Hydroxybuterate/G6PD/Sickle testing are not currently been done in chemistry department.

4. Please confirm current water vendor in use.

Response: Abbott Laboratories is the current prime contractor.

5. Please allow a two-week extension post the last answers posted to the respond as we respectfully request our questions clarified and it will allow ample time to respond and to prepare a thorough and thoughtful response to your request for solicitation.

Response: The solicitation was extended by one week. Due date is 2:00 PM Central Standard Time on Friday, 7 April 2023.

6. Reference Page 26/92 of the W81K document, under section III- PRICE:

NOTE: This is an “all or none” solicitation. Failure to provide a unit price for any test listed in Exhibit “B”, unless the offeror states "not separately priced" within the attachment, will be construed to mean the offeror is not quoting that test and thus, not eligible for award.

Question/Point of Clarification: This statement does not allow for fair and open competition, This statement is source limiting, in that today you are either sending this out, using an alternative instrument, or limiting selection to one vendor by changing your testing method, thus not allowing for fair and open competition.

Response: If the tests are not currently being done at Carl R. Darnall Army Medical Center (CRDAMC), Fort Hood, Texas the Government wants to start doing those test at CRDAMC.

7. Reference Page 73/92 Scope of Work f. System capable of performing sickle cell testing as well as Hemoglobin A1C testing.

Question/Point of Clarification: This sickle is not listed on the exhibit test list. Is this currently being performed on a different platform? Is this a requirement to perform this testing on the automated core laboratory system?

Response: Section 2.4 of the Performance Work Statement has been updated to remove Sickle Cell testing.

8. Reference Page 74/92 l. 9-minutes or less STAT immunochemistry tests to include Troponin.

Question/Point of Clarification: This prevents for full and open competition and is source limiting, as only one vendor states that they provide this capability.

Response: Section 2.4 of the Performance Work Statement has been updated to no greater than 15-minutes.

9. ABSTRACT Page 74/92 2.5 Integration: 2.5.1 Integration below:

2.5.1. The Contractor shall provide plans to integrate existing Government owned coagulation, hematology, urinalysis equipment and instrumentation with a track system with the primary goal of improving turn-around time and minimizing manual repetitive movement of patient specimens and aliquots, by laboratory technicians. This includes, at minimum, integration of system logic hardware and software, centrifugation, capping/uncapping of samples, making of aliquots, cold storage, and retrieval of specimens.

Question/Point of Clarification: Please identify the analyzers that you are requesting be connected by name.

Response: Performance Work Statement has been updated to remove the requirement.

The following have been modified:

PERFORMANCE WORK STATEMEONT

Performance Work Statement

1. General:

Contractor shall provide two identical clinical chemistry analyzers, two identical immuno-chemistry analyzers, an automated track system, and storage module on a cost –per-reportable result (CPRR) basis. This CPRR program shall include equipment, service and consumables for an estimated test volume of 105,856 immuno-assay tests per year, and 1,034,238 clinical chemistry tests per year. Overages shall be built into the CPRR as a separate line item. Contractor shall provide unscheduled maintenance according to include parts, and labor on the automated systems located at Carl R. Darnall Army Medical Center (CRDAMC), 36065 Santa Fe Avenue, Fort Hood, Texas.

2. Scope of Work:

The Contractor shall provide all necessary trained experienced personnel, labor, tools, diagnostic equipment and software, material, supplies, transportation, parts and equipment, including expendable items to perform repair support of the automated chemistry system. Service shall consist of four (4) quarterly Preventive Maintenance (PM) and unlimited repair calls (24/7 availability via hot-line) and shall be performed as described and recommended in accordance with the service manual.

All equipment shall be in compliance with Authority to Operate/Risk Management Framework (ATO/RMF). Any updates to the equipment after receipt of an approved ATO shall be approved by the Defense Health Agency’s Cybersecurity Team.

Ninety (90) percent of all Lab personnel shall be trained within thirty (30) days of installation. The contractor shall provide training for two (2) Operator Level Training per analyzer initially and one (1) Operator Level Training per analyzer annually. The expense for the initially and annual training shall be borne by the contractor at no additional cost to the Government.

2.1. Normal Duty Hours: Monday through Friday 7:30 am. to 4:30 p.m., excluding national holidays and weekends.

2.2. Contractor shall report within two hours to Chemistry Department, CRDAMC, 36065 Santa Fe Avenue, Room 42-456.

2.3. After Duty Hours: Contractor shall report to the Administrative Officer of the Day (AOD) at the front desk of the hospital to be escorted to the appropriate work area.

2.4. The Contractor shall provide analyzers with the following specifications:

a. Minimum of 1000 samples per hour processing capacity

b. Minimum of 300 samples direct loading capability with STAT prioritization.

c. Minimum of 300 samples direct unloading or bi-directional connectivity to lab automation.

d. General chemistry instrumentation processes a minimum of 800 tests per hour

e. Immuno-chemistry instrumentation processes a minimum of 600 tests per hour.

f. System capable of performing Hemoglobin A1C testing.

g. Storage and retrieval system that can store up to 10,000 samples, handle waste disposal, and have the ability to automatically retrieve samples for reflex testing and add-ons.

h. Analyzer modules must have capability to operate as single modules, such that if one module goes down, the other modules are unaffected and still able to produce patient results. All instrumentation will have common system software.

i. Middleware system interfaced with chemistry analyzers that shall include rules based data including delta checks, moving averages, specimen exceptions, critical parameters, and quality control data.

j. Track system that supports third-party connectivity

k. Bi-directional interface with host query

l. No greater than 15 minutes for STAT immunochemistry tests to include Troponin.

m. Installation and initial validation of automated chemistry equipment

n. Auto-verification of chemistry results shall interface into Cerner/MHS Genesis or DoD-approved electronic medical record.

o. Integrated quality control system with access to peer data

p. CPRR contract-includes reagents, calibrators, quality controls, consumables, diluents, washes, etc., necessary to run analyzer efficiently as well as including any software updates, PM materials/tubing/supplies, etc. necessary for optimum functioning of the analyzer.

2.5 Integration:

2.5.1. Reserved

2.5.2. The Contractor shall coordinate with Hospital Medical Logistics, Hospital Medical Maintenance, and Hospital Information Technology Teams, and the manufacturers of Government owned equipment to implement the physical, systematic, and communicational requirements with the integrated lab equipment and the laboratory’s Federal Electronic Health Record, to the new chemistry automation line and track system. For instances if Government owned equipment that cannot be fully integrated into the automation line, the Contractor shall provide recommendations to the lab management of equipment, information systems, and middleware components that are compatible with the projected automation line, and that have compatibility with the DOD Electronic Health Information System.

2.5.3. The Contractor shall provide a redundant and independent Uninterrupted Power Supply (UPS) to cover one hour of main power loss for each major component of the new equipment, and any other Government owned equipment integrated into the automation line, if not already in use or provided by the Government.

2.5.4. The Contractor shall provide an independent and Original Equipment Manufacturer (OEM) compatible DI water filtration systems for each major component of the automation line, and any other Government owned equipment requiring filtered water, if not already in use, or provided by the Government. Where DI water filtration systems are compatible between varied OEMs of new and existing Government owned equipment, the water filtration systems shall be easily or automatically switchable by laboratory technicians to provide redundant water supply to other components in the event of failure, repair, or maintenance down-time of one or more water filtration systems. The Contractor shall also provide a UPS for the DI water filtration systems sufficient to cover no less than one hour of main power loss to all water filtration systems. Optionally, if sustainable for no less than one hour, the water filtration systems may receive back-up power from the UPS systems.

2.6. Core Lab Chemistry Platform Replacement:

2.6.1. Design: Drawings are provided under filer for MEM-15-0105, Contractor shall use and coordinate design into a constructed finished product. Upon award the Facility Management team shall meet with Facility Management Contractor personnel, Contracting Officer Representative and Contracting Officer to review the specifications, intent and drawings prior to construction. The Contractor shall provide the Facility Management team a project schedule, including a timeline for completion of all contract requirements, to include submittal process, construction time, commissioning, final cleanup, pre-final inspection, final inspection and acceptance, and any other milestones for definable features of work, shall be developed and included in the schedule.

2.6.2. Upon award the contractor shall provide the Laboratory Medical Director, Laboratory Manager, Contracting Officer Representative and Contracting Officer with a written plan for, and coordinate for, the movement, integration, and re-validation, of any new or Government owned or Government leased equipment without disruption of the laboratory’s established STAT or ASAP turn-around times for all lab assays, prior to integration into the automation line. Any recognized and unavoidable delays in established STAT or ASAP turn-around times must be provided in writing to the Contracting Officer for prior authorization.

2.6.3. Construction Action: The Contractor shall provide all labor, materials, and equipment necessary to support para. 1 General in room 42-415. The Construction effort is dependent on the Contractors approved design, means, and methods; construction efforts may include, but not limited to, demolition and replacement of existing cabinets, reconfiguration of power supply from Electrical Closet 42-450 to the equipment, data, compressed air, and plumbing features as required to generate a clear floor space for the installation of the new automated line analyzers. All work shall be accomplished in accordance with Federal, State, and Local codes, laws, regulations, policies, to include applicable NFPA’s, UFC 4-510-1, International Organization for Standardization (ISO) 15189, The College of American Pathologists (CAP), The Joint Commission, MEDCEN Regulation 40-78 (Risk Assessment). All replacement materials shall be new and match existing finishes. All utility outages and the pathway for bringing and taking out equipment and supplies shall be coordinated a minimum of 14 days in advance. All submittals shall allow for a 14-day Government review period. The Contractor shall warranty all construction work for one year from date of Government acceptance. The Contractor shall submit a warranty management plan, warranty documents, all applicable test reports and certifications prior to Government acceptance of work. If the contractors design and work execution results in reconfiguration of building systems, then the contractor shall submit Final as-builts in CADD and PDF format within two weeks after acceptance of construction.

2.6.4. Incidental Design: The Contractor shall prepare incidental construction design documents to clearly describe their plan of work for completing the requirements of this project. The incidental design documents shall address all aspects of the work to be performed.

ITEMS TO BE INCLUDED IN DESIGN DOCUMENTS:

a. Narrative description of work required, taken directly from site survey report when available.

b. Sketches of the required modifications if applicable.

c. Material take-offs.

d. Catalog cuts and equipment specs.

e. Manufacturers' installation procedures or execution specifications.

f. Original scope of work.

g. Work schedule (Phasing when required).

h. Infection Control Risk Assessment (ICRA) and containment plan.

The contractor shall comply with MEDCEN 40-78 and implement risk mitigating controls per the Risk Assessment Team’s guidance to ensure all work performed are risk assessed.

2.6.5. The Contractor will provide consultation, demonstration, and training to the Laboratory Staff, to include as applicable, Laboratory Medical Director, Laboratory Manager, Deputy Laboratory Manager, Laboratory NCOIC, Core Laboratory OIC, Core Laboratory NCOIC, Chemistry Supervisor, Lead Chemistry Technologists, Chemistry OIC, Chemistry NCOIC, Laboratory Quality Assurance Specialist, and Laboratory Information Specialist, on functions of weekly, monthly, quarterly, and annual Quality Assurance (QA) Reports, Management Reports, reagent usage rates, and other metrics as required by established CAP, Hospital, and internal Laboratory Policies, or others reports to be directed by the Laboratory Medical Director, Laboratory Manager, and/or Deputy Laboratory Manager.

3. Personnel Qualifications:

The Contractor shall provide documentation that the field service technicians are qualified and manufacture trained on all new equipment, including UPS, and DI water filtration systems. The Contractor prior to service commencing shall present to the Contracting Officer Representative, documented proof of successful completion of such training.

4. Contract Representative (POC).

The Contractor shall provide in writing on the contract start date, the name and telephone number of a primary and alternate individual to act as their representative to be responsible for the coordination of the contract with the Government. The contractor’s designated representative shall be the point of contact with the Government and shall have the authority to act or make decisions for the Contractor on all matters pertaining to the contract.

The Contracting Officer Representative shall be notified in writing within 72 hours, whenever changes are made.

5. Quality Control:

5.1. The Contractor shall establish and maintain a Quality Control Plan to ensure that the quality of service and material provided meet or exceed the specifications, terms and conditions of the contract. All repairs or modifications that are made shall be in compliance with the manufacturer’s specification and Food and Drug Administration guidance.

5.2. The Government shall establish and maintain a Quality Assurance Plan to ensure that the quality of service is being provided and meet and exceed the specifications, terms and conditions of the contract.

6. Definitions:

6.1. Scheduled Maintenance: The scheduled care and servicing of equipment for the purpose of the equipment in a serviceable condition in accordance with the manufacturer’s specifications.

6.2. Unscheduled Maintenance: Repair action necessary to return the equipment to a totally operational condition as it was designed to operate in accordance with the manufacturer’s specifications.

6.3. Quality Control Plan: The Contractors’ written plan shall describe how the contractor will ensure the performance of the services required by the contract are met or exceeded. At a minimum, the Contractor’s Quality Control Plan shall include:

a. Method for acquiring acceptable replacement parts.

b. Inspection intervals and a copy of the checklist to be used by the Contractors QA Inspector.

6.4. Replacement Part: A component or module of the existing system or approved upgraded/modified system requiring replacement through a fault developed through normal use or normal wear and tear. Replacement parts do not include consumable supplies. Replacement parts include components that are installed solely for cosmetic appearance i.e. cowlings, molding, keyboard keypads (when the key designation is work off), etc.

6.5. OEM: Original Equipment Manufacturer.

6.6. FSE: Field Service Engineer

7. Government Furnished Services:

7.1. Equipment: The equipment covered under this contract shall be made available to the Contractor for the purpose of scheduled or unscheduled service. The Contractor shall obtain Contracting Officer Representative (COR) approval for the time and duration of the service to be conducted and shipping instructions.

7.2. Property: The Contractor shall not use property provided by the Government for any purpose other than in the performance of this contract.

7.3. Utilities: Reasonable amounts of electric power and other utilities shall be provided to the Contractor to perform required services. The Contractor is responsible for conserving utilities while working in the installation.

7.4. Contractor Furnished: Only the property and services referenced in paragraph 7.1 and 7.2 shall be provided to the Contractor to perform required services. All other property and services required in the performance of this contract shall be furnished by the Contractor.

For example:

7.4.1. Tools

7.4.2. Test equipment

7.4.3. Current service manuals with guaranteed ability to provide product updates, guaranteed to provide factory mandated instrument modifications, schematics, wiring diagrams and troubleshooting guides (failure to provide product updates or factory mandated modifications is grounds for contract termination).

7.4.4. All other items necessary to perform service such as common hardware, connectors, tubing and etc.

8. Replacement Parts:

The Contractor shall have ready access to unique and/or high mortality replacement parts. All parts supplies shall be compatible with the automation line and integrated equipment.

8.1. Freight, postage and storage charges associated with shipment and receipt of replacement parts and the return of broken or defective parts shall be the responsibility of the contractor.

8.2. The Contractor shall use only new or reconditioned parts for which the quality is equal to or better than the OEM’s original part. Any parts provided by the Contractors that are considered by the OEM to be substandard shall be replaced at the Contractor’s cost.

When discrepancies occur, the Contracting Officer Representative shall make the final determination about whether a replacement part is of equal or better quality.

8.3. The Contractor shall provide all replacements and service necessary to restore the equipment to 100% operational condition as specified by the OEM.

9. Coordination for scheduled and unscheduled services:

Preventive maintenance shall be performed in accordance with the manufacturer’s specifications during the specified month. The Contractor shall coordinate 15 days in advance with the Contracting Officer’s Representative or Department, for preventive maintenance, certification, and calibration. The service technician shall provide online/internet support (IF APPLICABLE) within twenty-four (24) hours of notification.

Government request for remedial repairs shall be placed telephonically by the Contracting Officer Representative to the Contractor’s Point of Contact.

The Contractor’s response to requests for remedial repairs may include a telephone consultation between the equipment user/operator or Government’s Service Technician and a Contractor’s Field Service Engineer (FSE).

The contractor shall provide customer service via telephone 24/7 for troubleshooting and technical support.

The purpose of this telephone consultation shall be:

9.1. To determine the most likely cause of the problem.

9.2. To determine if resolution of the problem requires the dispatch of a FSE once determination has been made that a Contractor’s FSE is required on site. The Contractor’s FSE shall have 24 hours to be on-site from the time of notification by the Contracting Officer Representative (and/or user/operator of the analyzer) to the Contractor and restored fully operational within 72 hours. If the user/operator notifies the FSE, then notification of the COR falls to the user/operator to be made as soon as possible, especially if this occurs after hours.

9.3. To identify replacement parts if any likely to be required in order to return the equipment to 100% operational condition as specified by the OEM. Failure of the Contractor to respond within the twenty-four (24) hour response time shall result in a two (2) percent deduction from the monthly contract payment.

9.4. In the event the two clinical chemistry analyzers, two immuno-chemistry analyzers, and automated track system is completely inoperable the Government will immediately contact the contractor’s customer service department for technical support.

If the system remains inoperable after receiving technical support all STAT tests will be diverted to the network immediately and non-STAT or routine 24 hours afterward. If it’s determined the system failure is due to a technical, mechanical or water failure the contractor will reimburse the Government for the difference of the cost of the tests that were over the contracted price.

For example: contracted price is $3 and the cost of the test that was diverted to the network is $5. Contractor shall reimburse the Government $2 that will be deducted from the next invoice.

9.5. The Government and the Contractor shall exchange hazard communication information before the commencement of any repair.

9.6. When required, the Contractor shall comply with the Occupational Safety and Health Administration (OSHA) lockout/tagout standard while performing maintenance on electrical equipment.

10. Scheduled/Unscheduled Maintenance documentation:

All scheduled and unscheduled maintenance shall be documented on a service report.

This form shall be furnished upon completion of service within five working days to the Department/ System Administrator via email or fax.

10.1 Service Reports:

The Contractor shall prepare a service report for each job performed. This report shall typically be e-mailed to the user/operator, and shall be submitted to the COR and/or the Medical Maintenance Branch. The service reports shall include the following information as a minimum:

1. Government contract number

2. Equipment identification data

3. System nomenclature, room number, location, model and serial number

4. Purpose of service (scheduled service or unscheduled service call)

5. Start date/time and completion date/time

6. Description of defect and corrective action taken

7. List of parts and cost. Total cost of service to include labor and parts

8. Explanations of any deferred or delayed repair action with an estimated completion date.

10.2. Calibration Documentation. All calibration services shall be documented by the Contractor on the service report.

10.3. Maintenance Logs: A maintenance log shall be maintained with the service technician for the system. The log shall be documented for any service performed. The log shall remain on-site with the system.

10.4. Scheduled Maintenance documentation: All scheduled maintenance shall be documented on a service report. This form shall be furnished upon completion of service to the Department, medical maintenance and the

COR.

11. Equipment Modification/Alteration/Upgrades:

11.1. The Contractor shall perform/incorporate only OEM specified modifications, alterations, and upgrades.

Approval shall be obtained from the Contracting Officer prior to the Contractor’s installation of the modification, alteration, or upgrade.

11.2. The Contractor shall perform or cause to be performed all OEM field modifications and safety alert inspections, to include product safety notifications in a timely manner.

11.3. The Contractor shall maintain contact with the OEM to determine the requirement for field modifications and to ensure accomplishment of these field modifications are in accordance with the time schedule set forth by the OEM.

11.4. The Contractor shall make known to the Contracting Officer Representative of minor or routine OEM software upgrades when they become available by the manufacturer.

11.5. Hardware and software changes not supported by the OEM are not authorized.

12. Contractor Reporting Requirements:

During normal duty hours the Contractor’s FSE shall notify the user/operator and/or Contracting Officer Representative upon arrival at the front entrance of the hospital for an escort. They shall receive their badge at the front desk through a picture I.D. badge exchange, where the contractor shall receive an “Escort Required” Badge.

If the user/operator is the escort, it shall be then their responsibility to notify the COR of the FSE’s arrival. Once the FSE departs, the COR shall once again be notified as well. In the event that the Contractor performs service beyond the normal duty hours, he/she shall sign-in and out with the Administrative Officer of the Day (AOD) at the information desk located on the main floor in the front lobby and be escorted to the laboratory.

13. Repair Parts:

All repair parts shall meet exact manufacturer’s specifications and be the most current revision level. All parts shall be new or remanufactured by the manufacturer of the instruments.

14. Services beyond the scope of the performance work statement:

The Contractor shall immediately, but not later than 24 consecutive hours after discovery, notify the Contracting Officer Representative (in writing) of the existence or development of any defects in/or repairs required to the equipment covered under this contract especially which the Contractor considers they are not responsible under the terms of the contract. At the same time of the notification, the Contractor shall furnish the Contracting Officer Representative with a written estimate of the cost to make the necessary repairs. Repairs requiring additional funding shall not be performed without prior written approval by the Contracting Officer.

15. Conduct of Personnel:

The Contracting Officer may require the Contractor to remove from the job site any employee working under this contract for reasons of misconduct, security, or found to be or suspected to be under the influence of alcohol, drugs or other incapacitating agent. Contractor employees shall be subject to dismissal from the premises upon determination by the Contracting Officer that such action is necessary and in the interest of the Government. In accordance with applicable directives and 18 U.S.C. 1382 (1972), the Installation Commander has the authority to bar individuals from the installation. The removal from the job site or dismissal from the premises shall not relieve the Contractor of the requirement to provide sufficient personnel to perform the services as required by this work statement.

16. Security Requirements:

16.1. Contractor personnel or any representative of the Contractor entering Fort Hood Army Installation shall abide by all security regulations and shall be subject to security checks.

16.2. Contractor personnel and property shall be subject to search and seizure upon entering the confines of Fort Hood Army Installation and while on the installation in accordance with AR 190-13 (The Army Physical Security Program).

17. Identification Badge:

Contractor personnel shall wear a vendor identification badge at all times when performing services at the Government site. Identification badges shall be worn in a clearly visible area of the FSE’s outer garment. The badge shall be furnished at the front desk during duty hours and by the Administrative Officer of the Day (AOD) after duty hours.

18. Access and general protection/security policy and procedures: Contractor and all associated sub-contractor employees shall provide all information required for background checks to meet installation access requirements to be accomplished by installation Provost Marshal Office, Director of Emergency Services and/or the CRDAMC.

Contractor workforce must comply with all personal identity verification requirements (FAR clause 52.204-9, Personal Identity Verification of Contractor Personnel) as directed by DOD, HQDA and all CRDAMC security requirements. In addition to the changes otherwise authorized by the changes clause of this contract, should the Force Protection Condition (FPCON) at any individual facility or installation change, the Government may require changes in Contractor security matters or processes. Contractor and all associated sub-Contractors employees shall comply with adjudication standards and procedures using the National Crime Information Center Interstate Identification Index and Terrorist Screening Database (TSDB) (Army Directive 2014-05/AR 190-13), applicable installation, facility and area commander access and local security policies and procedures.

19. iWatch Training. The Contractor and all associated sub-Contractors shall brief all employees on the local watch program. All personnel shall view the iWatch video on at http://www.crdamc.amedd.army.mil/videos/iwatch.aspx .

All personnel on CRDAMC property must understand to contact 288-COPS (288-2677) or the CRDAMC Provost Marshal Office at 553-9832 if any suspicious activity is observed. This training shall be completed by all Contractors working in CRDAMC facilities for any period of time. This training shall be completed within 14 calendar days of contract award or within 14 calendar days of new employees commencing performance with the results reported to the COR within 5 days of completion.

20. Service Contract Reporting:

"Accounting for Contract Services-The Office of the Assistant Secretary of the Army (Manpower &Reserve Affairs) operates and maintains a secure Army data collection site where the contractor will report ALL contractor manpower (including subcontractor manpower) required for performance of this contract. The contractor is required to completely fill in all the information in the format using the following web address “https://SAM.gov.” The required information includes: (1) Contracting Office, Contracting Officer, Contracting Officer’s Technical Representative; (2) Contract number, including task and delivery order number; (3) Beginning and ending dates covered by reporting period; (4) Contractor name, address, phone number, e-mail address, identity of contractor employee entering data; (5) Estimated direct labor hours (including sub-contractor); (6) Estimated direct labor dollars paid this reporting period (including sub-contractor); (7) Total payments (including sub-contractor); (8) Predominant Federal Service Code (FSC) reflecting services provided by contractor (and separate predominant FSC for each sub-contractor if different); (9) Organizational title associated with the Unit Identification Code (UIC) for the Army Requiring Activity (the Army Requiring Activity is responsible for providing the contractor with its UIC for the purposes of reporting this information); (10) Locations where contractor and sub-contractors perform the work (specified by zip code in the United States and nearest City, Country, when in an overseas location, using standardized nomenclature provided on website); (11) Presence of deployment or contingency contract language, and, (12) Number of contractor and sub-contractor employees deployed in theater this reporting period (by country).

(13) As part of its submission, the contractor will also provide the estimated total cost (if any) incurred to comply with this reporting requirement. Reporting period will be the period of performance not to exceed 12 months ending September 30 of each government fiscal year and must be reported by 31 October of each calendar year. The contractor shall notify the Contracting Officer’s Representative (COR) by the 5th working day of November whether or not they have completed this report. If the COR is unavailable, the contractor will notify the Contracting Officer."

DELIVERABLES

REQUIRED OUTCOME PERFORMANCE

OBJECTIVE/

STANDARD

Maximum Allowable Degree of Deviation from Requirement

(AQL)

Surveillance Method

Performance Incentive

Provide four quarterly PMs as scheduled by CRDAMC Chemistry Department

Provide instrumentation PM on scheduled dates

No more than 1 day late Observation by COR

Performance above or below the standard will be documented in supplier satisfaction documentation

Provide high quality consumables (reagents, QC, etc) for specimen testing

Provide all reagents and consumables on required dates defined by terms of contract

No more than 2 days prior to start date

Observation by COR

Performance above or below the standard will be documented in supplier satisfaction documentation

Provide emergency support to CRDAMC Chemistry Department 2 hours from verbal notification

Provide emergency support as requested

No more than 1 hour over the initial 2 hour window, 3 times in the term of the contract

Observation by COR

Performance above or below the standard will be documented in supplier satisfaction documentation

Training of repair personnel is specific to the instrumentation at CRDAMC and is current

Training is current for

CRDAMC

instrumentation

Training is current 95% of the time

Observation by COR

Performance above or below the standard will be documented in supplier satisfaction documentation

Repair personnel will have at least 2 years of experience with instrumentation at CRDAMC

Monitored at the point of service

Zero tolerance Observation by COR

Performance above or below the standard will be documented in supplier satisfaction documentation

Contractor will notify CRDAMC of any reagent or kit recall within 24 hours of initiating the recall

Provide notification of reagent/kit recalls timely

Zero tolerance Observation by COR

Performance above or below the standard will be documented in supplier satisfaction documentation

Contractor will provide telephonic support 7 days a week, 24 hours a day

Provide support to CRDAMC staff 7 days a week, 24 hours a day

Zero tolerance Observation by COR

Performance above or below the standard will be documented in supplier satisfaction documentation

Contractor will provide training (at no expense to the Government) for 2 operator-level training per analyzer initially and one operator per analyzer annually. Supervisor training provided.

Provide training prior to installation of instruments.

90% of staff trained within 30 days of install.

Observation by COR

Performance above or below the standard will be documented in supplier satisfaction documentation

Contractor will provide a team of qualified personnel to implement and validate the new instrumentation at CRDAMC Chemistry Department

Provide initial validations for new instrumentation

Within 30 days of installation

Observation by COR

Performance above or below the standard will be documented in supplier satisfaction documentation

QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

The following minimum Quality Assurance Plan applies. The Government may modify inspection methods in accordance with site specific requirements.

PERFORMANCE

OBJECTIVE

PERFORMANCE

STANDARD

REF PWS METHOD OF

ASSESSMENT

The automated chemistry service technician shall perform four quarterly visits for the purpose of inspection, adjustment, and maintenance on all equipment.

Documentation in accordance with regulations, established guidelines for CAP, CLIA, JCAHO, etc

2 COR Review

Quality Control Plan 5 days after award and when changes are made to the plan.

5 COR Review/ Maintenance Logs

Analyzer, track, and storage downtimes need to be minimized to no more than 1X per quarter.

Documentation by service records.

2 COR Review/ Maintenance Logs

Automated chemistry service shall respond by phone 24 hour availability

Comply initially and as required 100% of the time.

2 COR Review and/or User/Operator Documentation

Automated chemistry service shall respond in person at no additional charge, within the normal business hours, within two (2) hours of notification.

Comply initially and as required 100% of the time.

2 COR Review and/or User/Operator Documentation

STANDARD MEASUREMENT PAST PERFORMANCE ASSESSMENT

99% to 100% Excellent Document Past Performance 96% to 98% Very Good Assessment Report, paying 95% Satisfactory particular attention to 92% to 94% Marginal performance that exceeds 92% or Less Unsatisfactory the standard

SUPPLEMENT TO THE PERFORMANCE WORK STATEMENT

GOVERNMENT HOLIDAYS

The following Government Holidays are observed:

New Year’s Day, January 1

Martin Luther King, Jr.’s Birthday, 3rd Monday in January

President’s Day, 3rd Monday in February Memorial Day, Last Monday in May Juneteenth Day, June 19 Independence Day, July 4

Labor Day, 1st Monday in September

Columbus Day, 2nd Monday in October Veteran’s Day, November 11

Thanksgiving Day, 4th Thursday in November Christmas Day, December 25

Note: Any of the above holidays falling on a Saturday will be observed on the preceding Friday; holidays falling on a Sunday will be observed on the following Monday. Any holidays that are declared by Presidential Executive Order shall be observed in the same manner as the holidays listed above

INVOICING AND PAYMENT MONTHLY

The contractor shall submit monthly, in arrears, itemized invoices in accordance with DFARS 252.232- 7003 & 252.232-7006, for services rendered under this contract. Information regarding Wide Area Workflow is available on the Internet at https://piee.eb.mil

CRIME CONTROL ACT OF 1990

No performance under this contract will be allowed without full compliance with the Crime Control Act of 1990 and the Department of the Army Circular 690-92-1, 15 November 1992, Criminal History Background Checks on Individuals in Child Care Services. Contractor shall ensure that proposed health care workers cooperate with and assist the Government in conducting any necessary background checks.

SHARP

Department of Defense Directive (DoDD) 6459.01, Sexual Assault and Response (SAPR) Program

TOBACCO FREE MEDICAL CAMPUS (TFMC)

The Contractor shall ensure that all contract personnel comply with the U.S. Army Medical Command and MTF smoking policies while performing services under this contract. Smoking restrictions will apply at any location or building where health care activities are performed under this contract.

In accordance with Army Regulation 600-63, paragraph 7-3, 14 April 2015; Operations Order 15-48 (Army Medical Command (MEDCOM) Tobacco Free Living – USAMEDCOM), 8 May 2015; and any Operations Order, regulation or other instruction implementing, defining or otherwise addressing the Tobacco Free Medical Campus (TFMC) on any military installation or DoD-controlled location, Contractor personnel are prohibited from using any tobacco product on or within any TFMC while performing under this contract. TFMCs are established at each installation or DoD-controlled location and include: (1) any property or non-residential building that is operated, maintained or assigned to support medical activities, including but not limited to, hospitals, medical laboratories, outpatient clinics (including medical, dental, and veterinary facilities), or aid stations operating for the primary purpose of delivering medical care and services for DOD eligible beneficiaries and /or meeting the mission of the

Army Medical Command; (2) all other facilities in which medical activities or administration take place, to include HQ MEDCOM and Defense Health Headquarters; (3) all internal roadways, sidewalks and parking lots; and (4) all sidewalks, parking lots and grounds external but adjacent to the building or related to the migratory corridors surrounding the medical facility. The contractor shall obtain from the COR any orders, regulations, instructions or other documents implementing, defining or otherwise addressing the TFMC for any given installation or DoD-controlled location where contractor personnel may perform under this contract and shall instruct contractor personnel on the TFMC limitations for installations or DoD-controlled locations where they may perform under this contract.

EXCLUSION FROM PARTICIPATION IN FEDERAL HEALTH CARE PROGRAM Exclusion from Participation in Federal Health Care Programs (October 2015)

1. The Contractor shall not employ or contract with any individual or entity (hereinafter collectively referred to as “person”) to provide items or services that will be included in invoices submitted to the Government under this contract if such person is listed on the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) List of Excluded Individuals and Entities (LEIE) or the TRICARE Sanctioned Provider List. The Government is legally prohibited from paying for provision of items or services by such persons. The prohibition extends to services beyond direct patient care, such as services of persons in executive or leadership roles and administrative and management services, whether or not such services are billed separately. The LEIE may be found at h ttp://oig.hhs.gov/fraud/exclusions.asp, and the TRICARE Sanctioned Provider list at h ttp://www.health.mil/Military-Health-Topics/Access-Cost-Quality-and-Safety/Quality-And-Safety-of-H ealthcare/Program-Integrity/Sanctioned-Providers. The LEIE and TRICARE Sanctioned Provider List are hereinafter collectively referred to as “the Lists.”

2. Prior to start of contract performance, the Contractor shall (a) query the Lists to determine whether the name of any person the Contractor employs or contracts with to provide services or items for which payment may be made under this contract appears on the Lists, and (b) certify to the Contracting Officer that the Contractor has queried the Lists and no such names appear on either of the Lists.

3. During performance of the contract, and prior to persons other than those whose names were queried in accordance with paragraph 2, above, (hereinafter “new persons”) providing services or items under the contract, the Contractor shall (a) query the Lists as in paragraph 2, and (b) certify to the Contracting Officer that the names of such new persons do not appear on either of the Lists.

4. The Contractor is advised that during performance of the contract, MTF personnel will perform a recurrent recheck of the names of contractor personnel working in the MTF against the Lists, as specified in OTSG/MEDCOM Policy Memo 15-037. The Government will notify the Contractor in the event any contractor personnel working in the MTF appear on either of the Lists.

5. Should any person providing items or services under the contract appear on either of the Lists at any time during contract performance, the Contractor shall (a) in cases where the Contractor identified the person, notify the Contracting Officer, and (b) promptly remove that person from the contract.

6. Violation of any aspect of the above paragraphs shall be considered a material breach of the contract and may result in termination of the contract.

7. The Contractor is further advised that, in accordance with Civil Monetary Penalties Law [CMP] (codified at 42 USC § 1320a-7a):

There are steep civil monetary penalties associated with billing the Government for providing items or services by a person on either of the Lists, and with failing to return to the Government any overpayments received for provision of such items or services.

Billing under the contract for provision of items or services by a person on either List may also result in exclusion of the person that employs or contracts with such person.

HHS OIG has issued a Special Advisory Bulletin on the Effect of Exclusion from Participation in Federal Health Care Programs with additional information on the CMP. The Special Advisory Bulletin may be found at h ttp://oig.hhs.gov/exclusions/files/sab-05092013.pdf.

Personally Identifiable Information, Protected Health Information, and Federal Information Requirements (Revised 10/27/2020)

1. General Requirements Overview - Personally Identifiable Information (PII), Protected Health Information (PHI) and Federal Information Laws

This Section addresses the Contractor’s requirements under The Privacy Act of 1974 (Privacy Act), The Freedom of Information Act (FOIA), and The Health Insurance Portability and Accountability Act (HIPAA) as set forth in applicable…