W9114F-17-T-0001-0001.doc

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 1449 - CONTINUATION SHEET

The following have been added by full text:

QUESTIONS AND ANSWERS

Question 1:

Is it possible to get the RFQ in Word-File format?

Answer 1:

Yes, this can be submitted by request.

Question 2:

When and exactly where is the in paragraph 52.212-1 (o) mentioned work site visit scheduled?

Answer 2:

Site Visit is scheduled for 3 November 2016 at 14:00. Location: LRMC BLDG 3705, 3rd Floor.

Question 3:

The following question is in regards to Line Item 0001 and PWS Paragraphs 5.1 (RFQ page 37) and 5.4.1.2 and 5.4.2.3 (RFQ page 42) where it states the following:

Line Item 0001 “Lease of two (2) Coagulation Analyzers in accordance with the Performance Work Statement”

“5.1. DESCRIPTION: The Contractor shall provide two (2) compatible, fully automated random access coagulation analyzers, capable of performing clotting, chromogenic and immunological assays listed in Table 1A, with a minimum throughput of 50 tests per hour, all sample and calibrator dilutions must be performed automatically. The Contractor shall provide all training, supplies, reagents, unscheduled maintenance, and preventive maintenance for the equipment. The methods must have a minimum peer group of 20 laboratories in the College of American Pathology (CAP) Surveys. All equipment displays and supporting literature must be in the English language. The analyzers will be located at the Landstuhl Regional Medical Center (LRMC), Building 3711, Room F203, 66849 Landstuhl, Germany. Lease of this equipment shall include delivery, installation, all calibrators/standards, reagents/reagent packs, and quality control materials necessary to perform the specified assays, initial Method Validations per CLIA/CLSI guidelines and analyzer removal at the termination of the contract.”

“5.4.1.2. The Contractor shall provide all personnel, equipment, tools, materials, supervision, parts, transportation, and other items and services necessary to perform all required repairs and scheduled preventive maintenance/safety inspections and calibrations of equipment. The performance of scheduled periodic preventive maintenance, safety checks, and calibrations that are not normally performed at the operator level shall be performed by Contractor service personnel in accordance with requirements as specified in the Contractor’s instrument maintenance manual. Completion of installation of the analyzers shall establish time zero for determination of time frames for performance of the above periodic services.

The Contractor shall provide a full unscheduled and preventive maintenance service for the lease period at no additional cost. Service shall include repair and replacement of defective parts, complete maintenance program (as required by the manufacturer’s maintenance manuals), and hotline telephone service, to assist operators in troubleshooting problems in accordance with paragraph 5.4.2.1 of this Performance Work Statement.”

“5.4.2.3. The Contractor shall provide a full unscheduled and Preventive Maintenance Service for the lease period. The lease agreement shall be inclusive of all costs for the performance of scheduled periodic maintenance (as required by the Contractor’s instrument maintenance manuals), unscheduled maintenance and repair of the analyzers and any associated equipment provided by the Contractor as part of the analyzer system, including replacement parts, replacement part shipment costs, and service technician travel costs for performance of maintenance services.”

Considering the above, can we assume that Line Item 0001 is to include Rental and Full Service?

Answer 3:

This is correct.

Question 4(a):

Can we assume that Line Item 0002 is the price per patient-result?

Answer 4(a):

This is correct.

Question 4(b):

Can we assume that the patient-results for Line Item 0002 request a price per result including all in PWS Paragraph 5.3.8. Table A1 shown Tests (PT, APTT, Fib-Clauss, D-Dimer) with a total of 8250?

Answer 4(b):

The values in the PWS Table A1 were an estimate (rounded up). A more exact usage (based on the last 12 months to the nearest 50) is listed below. The PWS was adjusted to be below values which match the number of patient results in Line Item 0002 and should be used for your quote.

Prothrombin Time (PT)

Activated Partial Thromboplastin Time (APTT)

Fibrinogen

D-Dimer

Total

Question 4(c):

Please clarify the quantity difference between Line Item 0002 (RFQ Page 3) and PWS Paragraph 5.3.8. Table A1 (RFQ Page 36 and 40):

“Line Item 0002 Quantity: 6,500 Unit: Each Reportable Tests in accordance with the Performance Work Statement (PWS) paragraph 5.3”

Table A1 – Listing of Required Assays and Annual Patient Testing Volume

(Does not include calibrators, controls or standards)

“Paragraph 52.212-1(q) If a Quoter believes that the requirements in these instructions contain an error, omission, or are otherwise unsound, the Quoter shall immediately notify the Contracting Officer (KO) in writing with supporting rationale.”

Answer 4(c):

See Answer 4(b) for revised number for Table A1 and explanation.

Question 5:

The following question is in regards to the provision 252.204-7011 ALTERNATIVE LINE-ITEM STRUCTURE (RFQ Page 61 & 62).

Can we assume that we can provide a quote with split prices which would be as follows:

ITEM NO 2 PT Test, Quantity 4000.

ITEM NO 3 aPTT Test, Quantity 3000.

ITEM NO 4 Fib-Clauss Test, Quantity 250.

ITEM NO 5 D-Dimer Test, Quantity 1000.

Answer 5:

Yes, you can do that, but please use the updated numbers from Answer 4(b) for a total of 6500.

Question 6:

The following question is in regards to PWS paragraph 5.3.7 where it states the following:

“5.3.7. The Contractor shall provide an estimate of the yearly quantities of reagent/reagent packs, calibrators/standards, and quality control materials required to perform the volume of tests for each assay as provided in Table A1. The Contractor shall ensure that requirements for routine quality control runs (as defined by LRMC DPALS QA program; three times daily, 365 days per year), routine calibration, periodic calibration/calibration verification (i.e., each assay must be calibrated or have calibration verification performed at intervals not to exceed a 6-month period of time), and for troubleshooting of out-of-control assays be considered when calculating the yearly requirements. The Contractor shall also estimate the volume of user-replaceable maintenance items that will be required to support the analyzer, and any analyzer specific tools/supplies necessary to perform operator-level periodic maintenance tasks, at the level of use specified in Table A1. All reagents and QC material shall conform to the published/stated specifications.”

Are you going to run 3 times normal and 3 times high controls a day (or e.g. 2 times normal and 1 time high a day)?

Answer 6:

Both levels of QC are run together, every 8 hours. Total of 3 x Normal and 3 x High each day.

Question 7:

The following question is in regards to PWS paragraph 5.4.2.7 which states the following:

“5.4.2.7. Emergency Services and unscheduled services outside regular working hours, on weekends, and on German Holidays will be listed as a separate line item. The Contractor’s qualified service technician shall be on-site to provide unlimited emergency service (service requiring immediate repair) within 24 hours. The equipment shall be repaired and operational within 72 hours after initial response by the Contractor.”

As there is currently no separate item in the solicitation, will this be added at time of award?

Answer 7:

All repair and unscheduled services are to be included in the lease cost, there is no need for a separate line item. The verbiage about the separate line item was removed from the PWS.

Please see PWS Paragraph 5.4.2.3:

“The lease agreement shall be inclusive of all costs for the performance of scheduled periodic maintenance (as required by the Contractor’s instrument maintenance manuals), unscheduled maintenance and repair of the analyzers and any associated equipment provided by the Contractor as part of the analyzer system, including replacement parts, replacement part shipment costs, and service technician travel costs for performance of maintenance services.”

The following have been modified:

PERFORMANCE WORK STATEMENT

PERFORMANCE WORK STATEMENT

FOR

LEASE OF COAGULATION ANALYZERS

1. GENERAL REQUIREMENTS:

1.1. SCOPE OF WORK: The Contractor shall provide non-personal services to include, but not limited to, all personnel, equipment, tools, materials, supervision, training, and other items and services necessary to provide two (2) Coagulation analyzer systems and reagents as required. The analyzers will be located at the Landstuhl Regional Medical Center (LRMC). The Contractor shall perform to the standards of this performance work statement.

1.2. CONTRACTOR PERSONNEL:

1.2.1. Contract Manager. The Contractor shall provide a contract manager who shall be responsible for the performance of the work. The name of this person, and an alternate or alternates, who shall act for the Contractor when the manager is absent, shall be designated in writing to the contracting officer.

1.2.1.1. The contract manager or alternate shall have full authority to act for the Contractor on all contract matters relating to daily operation of this contract.

1.2.1.2. Based upon the request of the Contracting Officer’s Representative (COR) the contract manager or alternate shall be telephonically respond within 4 hours and be on site during normal duty hours within 24 hours to meet on the installation with Government personnel (designated by the contracting officer) to discuss problem areas. After normal duty hours (weekends and holidays), the manager or alternate shall be available within 72 hours.

1.2.1.3. The contract manager and alternate(s) must be able to read, write, speak, and understand English. All other Contractor representatives shall be sufficiently fluent in the English language to effectively communicate with Landstuhl Regional Medical Center’s (LRMC) representatives.

1.2.2. Contractor Employees. The Contractor shall not employ persons for work on this contract if such employee is identified to the Contractor by the contracting officer as a potential threat to the health, safety, security, general well-being or operational mission of the installations and their population.

1.2.2.1. Contractor personnel shall present a neat appearance and be easily recognized as Contractor employees. Contractor personnel shall either wear a distinguishable uniform or badge on the exterior of their clothing while performing any service at any U.S. Government facility.

1.2.2.2. The Contractor shall make sure employees have the following current and valid professional certifications before starting work under this contract. The Trainers and Product Specialists must have a 2 or 4 year certification in Medical Technology or Clinical Laboratory Sciences or similar European certification.

1.2.2.3. The Contractor shall not employ any person who is an employee of the U.S. Government if employing that person would create a conflict of interest. Additionally, the Contractor shall not employ any person who is an employee of the Department of Defense, either military or civilian, unless such person seeks and receives approval according to DOD 5500.7R, “Joint Ethics Regulation”. The Contractor shall not employ any person who is an employee of the Department of Defense if such employment would be contrary to local policies.

1.2.2.4. The Contractor is cautioned that off-duty active military personnel hired under this contract may be subject to permanent change of station, change in duty hours, or deployment. Military Reservists and National Guard members may be subject to recall to active duty. The abrupt absence of these personnel could adversely affect the Contractor's ability to perform, however, their absence at any time shall not constitute an excuse for nonperformance under this contract.

1.2.3. Security Requirements. The Contractor and employees must possess a valid passport and local national identification card. Contractor employees must comply with the installation entrance requirements which may include sign-in, being accompanied by an escort, and fingerprinting. Contractor employees are not required to complete AT/OPSEC training.

1.2.4. Employee Training. All Contractor training shall be furnished by the Contractor at no expense to the Government.

1.3. QUALITY CONTROL:

1.3.1. In compliance with the contract clause FAR 52.246-2 entitled "Inspection of Services – Fixed Price", the Contractor shall provide a Quality Control Plan that contains, as a minimum, the items listed in 1.3.2 to the contracting officer for acceptance not later than the start date of the contract. The contracting officer will notify the Contractor of acceptance or required modifications to the plan before the contract start date. The Contractor shall make appropriate modifications and obtain acceptance of the plan by the contracting officer before the contract start date.

1.3.2. The plan shall include:

1.3.2.1. A description of the inspection system to cover all services listed on the Performance Requirements Summary (PRS). Description shall include specifics as to the areas to be inspected on both a scheduled and unscheduled basis, frequency of inspections, and the title and organizational placement of the inspectors. Additionally, control procedures for any Government provided keys or lock combinations shall be included.

1.3.2.2. A description of the methods to be used for identifying and preventing defects in the quality of service performed.

1.3.2.3. A description of the records to be kept to document inspections and corrective or preventive actions taken.

1.3.3. The records of inspections shall be kept and made available to the Government throughout the contract performance period and for the period after contract completion until final settlement of any claims under this contract.

1.4. QUALITY ASSURANCE. According to the Inspection of Services clause, the Government will evaluate the Contractor's performance under this contract. For those tasks listed on the PRS (Technical Exhibit 1), the contracting officer’s representative (COR) or evaluators will follow the methods of surveillance specified in this contract. Government personnel will record all surveillance observations. The initialing of the observation does not necessarily constitute concurrence with the observation, only acknowledgment that he or she has been made aware of the defective performance. Government surveillance of tasks not listed in the PRS or by methods other than those listed in the PRS (such as provided for by the Inspection of Services clause) may occur during the performance period of this contract. Such surveillance will be done according to standard inspection procedures or other contract provisions. Any action taken by the contracting officer as a result of surveillance will be according to the terms of this contract.

1.4.1. Performance Evaluation Meetings. The contracting officer may require the contract manager to meet with the contracting officer, contract administrator, COR, and other Government personnel as deemed necessary. The Contractor may request a meeting with the contracting officer when he or she believes such a meeting is necessary. Written minutes of any such meetings shall be recorded in the contract and signed by the contract manager and the contracting officer or contract administrator. If the Contractor does not concur with any portion of the minutes, such non-concurrence shall be provided in writing to the contracting officer within 10 calendar days following receipt of the minutes.

1.5. PHYSICAL SECURITY. The Contractor shall be responsible for safeguarding all Government property provided for Contractor use or access.

1.6. HOURS OF OPERATION:

1.6.1. Normal Hours of Operation. The Contractor shall perform the services required under this contract during the following hours: Monday through Friday between the hours of 0700 - 1700.

1.6.1.1. Holidays. Routine services and reagent delivery shall not be required on standard U.S. Federal Holidays. If an emergency arises, services and reagent delivery shall be rendered between the hours of 0800 – 1200.

1.6.2. The Contractor shall provide same day customer service and support, Monday to Friday from 0800 to 1700, to include hotline telephone service to assist operators in correcting equipment operation problems and has to be on site within 24hrs if requested by the COR. A technically qualified person shall be available at all times and shall be fluent in speaking English.

1.7. CONSERVATION OF UTILITIES. The Contractor shall make sure employees practice utilities conservation. The Contractor shall be responsible for operating under conditions that prevent the waste of utilities to include:

1.7.1. Lights shall be used only in areas where work is actually being performed.

1.7.2. Employees shall not adjust mechanical equipment controls for heating, ventilation, and air conditioning systems.

1.7.3. Water faucets or valves shall be turned off when not in use.

1.7.4. Environmental and Hazardous Materials Handling. If the disposal of any waste or byproduct of the analyzers cannot be safely dumped into each of the facility’s drain system, the Contractor must provide guidelines for safely disposing these wastes or byproducts in accordance with local national guidelines.

1.8. RECORDS. The Contractor shall be responsible for creating, maintaining, and disposing of only those Government required records that are specifically cited in this PWS or required by the provisions of a mandatory directive listed in section 6, Applicable Publications and Forms. If requested by the Government, the Contractor shall provide the original record, or a reproducible copy of any such record within 5 working days of receipt of the request.

1.9. SHARP.

1.9.1 The contractor shall comply with OTSG/MEDCOM Policy Memo 16-033, OTSG/MEDCOM Policy Memo 16-033, Sexual Harassment/Assault Response and Prevention (SHARP) Program, 29 March 2016. The SHARP reporting requirements apply only to knowledge obtained by contractor personnel while performing services under this contract.

1.9.2 The contractor shall require all Contract Service Providers (CSP) with knowledge of an incident of sexual assault occurring on a Government facility, to include a Government leased facility, where the contractor is providing services under this contract, to report the incident to the contractor who shall immediately (within 24 hours) report the incident in writing to the government's COR. All incidents shall be reported whether they involve contractor personnel or Government personnel, or other individuals.

1.9.3 The contractor shall require all CSPs with knowledge of an incident of sexual harassment occurring on a Government facility, to include a Government leased facility, where the contractor is providing services under this contract, to report the incident to the contractor who shall immediately (within 24 hours) report the incident in writing to the government's COR. All incidents shall be reported whether they involve contractor personnel or Government personnel, or other individuals.

2. DEFINITIONS/ACRONYMS.

2.1. DEFINITIONS. Following is a list of basic definitions.

2.1.1. CONTRACTING OFFICER: A person with the authority to enter into, administer, and/or terminate contracts and make related determinations and findings.

2.1.2. CONTRACTING OFFICER'S REPRESENTATIVE (COR): A Government employee selected and designated in writing by the Contracting Officer to act as his/her designated representative in administering a contract.

2.1.3. QUALITY ASSESSMENT AND IMPROVEMENT. Those actions taken by the Government to check services to determine if they meet the requirements of the CLIA/DoD CLIP ’88 & ’03, CAP, JCAHO, U.S. Army Medical Command, quality assurance and risk management program, and ensure compliance with the terms and conditions of the contract

2.1.4. QUALITY CONTROL. Those actions taken by a Contractor to control the performance of services to ensure that they meet the requirements of the contract.

2.1.5. SERVICES: Includes services performed and materials furnished or utilized in the performance of those services

2.1.6. QUALITY IMPROVEMENT (QI): Those actions taken by the Government, in accordance with AR 40-68, to assure services meet the requirements of the Performance Work Statement (PWS).

2.2. ACRONYMS/ABBREVIATIONS. Following is a list of basic acronyms/abbreviations used in the contract.

AKO

Army Knowledge Online

ALMS

Army Learning Management System

AMR

Analytical Measurement Range

APTT

Activated Partial Thromboplastin Time

AR

Army Regulation

CAP

College of American Pathologists

CD

Compact Disk

CDR

Contract Discrepancy Report

CFR

Code of Federal Regulation

CHCS

Composite Health Care System

CLIA

Clinical Laboratory Improvement Amendments of 1988

CLIN

Contract Line Item

CLIP

Clinical Laboratory Improvement Program

CLSI

Clinical and Laboratory Standards Institute

COR

Contracting Officer's Representative

CSP

Contract Service Providers

DA

Department of the Army

DoD

Department of Defense

DPALS

Department of Pathology and Area Laboratory Services

DVT

Deep Vein Thrombosis

FAR

Federal Acquisition Regulation

FDA

U.S. Food and Drug Administration

FSC

Federal Service Code

HIPAA

Health Insurance Portability & Accountability Act of 1996

LRMC

Landstuhl Regional Medical Center

MAS

Minimum Acceptable Standards

MEDCOM

Medical Command

MTF

Medical Treatment Facility

JCAHO

Joint Commission on the Accreditation of Health Care Organizations

JC

The Joint Commission

OSHA

Occupational Safety and Health Administration

PE

Pulmonary Embolism

PMS

Preventive Maintenance Services

POC

Point of Contact

PRS

Performance Requirements Summary

PT

Prothrombin Time

PWS

Performance Work Statement

QA

Quality Assurance

QA&I

Quality Assessment & Improvement

QASP

Quality Assurance Surveillance Plan

QC

Quality Control

QI

Quality Improvement

RFQ

Request for Quotation

RHCE

Regional Health Command Europe

SDS

Safety Data Sheets

SHARP

Sexual Harassment/Assault Response & Prevention

UIC

Unit Identification Code

UPS

Un-interruptible Power Supply

U.S.

United States

USAMEDCOM

U.S. Army Medical Command

USAREUR

U.S. Army Europe

3. GOVERNMENT‑FURNISHED FACILITIES, EQUIPMENT, MATERIAL, AND SERVICES

3.1. GENERAL. The Government will provide, without cost to the Contractor, the facilities, equipment, materials, and services listed below.

3.1.1. FACILITIES. The Government will furnish the facilities for set-up and operation of the analyzers as indicated in paragraph 5.6 of the PWS. The Contractor shall not alter the facilities without written approval of the Contracting Officer. The Contractor shall return the facilities to the Government in the same condition as received, fair wear and tear and approved modifications excepted. These facilities shall be used for performance of this contract only.

3.1.2. EQUIPMENT. No equipment will be provided

3.2. MATERIALS. No materials will be provided.

3.3. SERVICES. The Government will provide the following services at no cost to the Contractor:

3.3.1. UTILITIES. The Government will provide the normal range of utilities, electricity, water, heating, refuse collection, etc., as is provided other personnel.

3.3.2. Security Police and Fire Protection, as is provided other personnel.

3.3.3. Emergency Healthcare for Contractor employees. The MTF will provide emergency healthcare for injuries occurring while on duty. The Contractor shall reimburse the Government for such services.

3.4. Government Unique Training. The contractor shall ensure all service providers receive Sexual Harassment/Assault Response and Prevention (SHARP) training not later than 60 calendar days after contractor personnel begin performance under this contract. Training can be obtained either online or in person. Contractor personnel can attend SHARP training provided by MEDCOM on an every other month basis by contacting (210) 221-6118 for class date/time and availability. If the employee has an AKO account, they can access online the Team Bound Self Study course through Army Learning Management System (ALMS) at http://www.atsc.army.mil/tadlp/delivery/alms.asp.

4. CONTRACTOR FURNISHED PROPERTY.

4.1. General. Except for those Government-furnished items and services specified in section 3, the Contractor shall furnish all items and services required under this contract.

4.2. Transportation. Transportation is the responsibility of the Contractor. The Government will not provide transportation.

4.3. Name tags. The Contractor shall furnish a nametag for each contract employee. The nametag shall contain the name of the company and the employee.

5. SPECIFIC TASKS:

5.1. DESCRIPTION: The Contractor shall provide two (2) compatible, fully automated random access coagulation analyzers, capable of performing clotting, chromogenic and immunological assays listed in Table 1A, with a minimum throughput of 50 tests per hour, all sample and calibrator dilutions must be performed automatically. The Contractor shall provide all training, supplies, reagents, unscheduled maintenance, and preventive maintenance for the equipment. The methods must have a minimum peer group of 20 laboratories in the College of American Pathology (CAP) Surveys. All equipment displays and supporting literature must be in the English language. The analyzers will be located at the Landstuhl Regional Medical Center (LRMC), Building 3711, Room F203, 66849 Landstuhl, Germany. Lease of this equipment shall include delivery, installation, all calibrators/standards, reagents/reagent packs, and quality control materials necessary to perform the specified assays, initial Method Validations per CLIA/CLSI guidelines and analyzer removal at the termination of the contract.

5.1.1. Contractor must coordinate and conduct a site visit to the LRMC Department of Pathology, building 3711, Room F203, for the purpose of surveying and assessing current laboratory set-up, laboratory environmental control, and available utilities with regard to potential placement of their instruments in the laboratory. Any changes to the layout of the laboratory, environmental control, or to utilities as currently in existence to accommodate placement of their proposed instruments must be identified in the Contractor’s Solicitation for Bid response (i.e., must identify all site preparation requirements necessary for potential placement of their instruments in the laboratory).

5.1.2. Method Validation will include, but not be limited to, normal range verification, demonstration of linearity with establishment of limits of quantitation (reportable range), correlation with current methods (comparison of methods study), validation of analytical measurement range (AMR), validation of precision (replication study) and accuracy (recovery study), and establishment of initial control ranges using LRMC supplied controls. All reagents, controls, calibrators and linearity materials shall be provided by the vendor.

5.1.3. The Contractor shall provide two (2) paper and two (2) CD copies of the Operator’s and Maintenance manuals and a statement of the warranty terms in the English language.

5.1.4. The analyzer system must be capable of interfacing with the military hospital computer system, i.e., the Composite Health Care System (CHCS). The Contractor must have an established driver compatible for interfacing the analyzer with the CHCS. The interface between CHCS and the analyzer must be bi-directional.

5.1.5. The analyzer shall have a Data Management system that provides on-line Levey-Jennings graphs and applies Westgard Quality Control Rules as selected by the user., and delta checks. Has a large capacity to store graphics and results, cumulative patient reports and quality control files with statistics - all available to user; capable of downloading the QC data to a disk which can then be used to submit the file for analysis against a QC peer group.

5.1.6. SAFETY DATA SHEETS (SDS): The Contractor shall provide safety data sheets (SDS) for each item delivered under this contract that is considered to be HAZARDOUS MATERIAL by the United States or the Contractor’s representative Government. The SDS shall contain information on the hazards associated with each specific chemical or material. The SDS shall be printed in the English language and shall contain, as a minimum, the following information: identification of the hazardous material and the specific hazard, the required practices for the safe use of the product, first aid procedures, and what to do in the event of a spill or other mishap or accident.

5.1.7. The Contractor shall provide a water system (e.g. filtered, deionized etc.), if required by the analyzer, that shall provide uninterrupted service for a minimum of three (3) days of operation.

5.1.8. The Contractor shall provide the reagents as outlined in the Schedule of Supplies/Services. Delivery of the reagents shall be as scheduled/required by the individual delivery orders issued by the contracting officer. The Contracting Officer representing the Europe Regional Contracting Office shall be the only entity authorized to issue orders against the resulting contract.

5.1.9. The Contractor shall be responsible for the collection and transportation of equipment upon termination of lease period.

5.1.10. The electrical requirement for this equipment must be 220V/50Hz.

5.1.11. English programs, keyboards, displays, on each instrument and printer.

5.2. ANALYZERS.

5.2.1. The analyzers must have the same test menu capability and utilize the same reagents/reagent packs, ensuring that a test’s reagents/reagent packs can be moved between the two instruments interchangeably. Each analyzer must provide all required coagulation test menu capabilities on the same individual instrument platform Additionally, each analyzer system must include a data management system for control of the operation of the analyzer system, management of the quality control program, management of the on-instrument useful life of the reagents/reagent packs, and management of patient results; and a printer for the production of hard copy patient reports and other reports generated via the analyzer system’s data management system. The data management system’s quality control program must include the ability to apply Westgard quality control result decision rules in real-time, with the ability of the user to individually select the rules to be applied.

5.2.2. Each analyzer shall be a random access, discrete analyzer system with immediate “STAT” interrupt capability and a primary tube sampling system capable of handling all tube sizes including pediatrics and micro container. Sample handling shall be automated, to include sample decapping or cap piercing. Each analyzer shall include a bar code scanner to automate identification of samples and reagents.

5.2.3. The analyzer systems shall provide users with rapid, reliable test results that are critical for patient care. These analyzer systems must be capable of performing in low, medium, and high volume work periods to produce results that are accurate and precise throughout the manufacturer’s stated linearity/analytic measurement range.

5.2.4. All analyzer/data management system displays and supporting literature must be in the English language.

5.2.5. Initial startup from the shutdown state must not exceed 20 minutes.

5.2.6. The analyzer systems must come equipped with an un-interruptible power supply (UPS) capable of providing all necessary electrical power to each analyzer system, to include the data management system, for 15 to 20 minutes. The UPS must be sufficient to complete the current sample run and power down the analyzer.

5.2.7. The analyzer systems and all reagents shall be FDA approved. The D-dimer assay must be FDA approved for the exclusion of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE).

5.2.8. The electrical requirement for the analyzer systems must be 220V/50Hz.

5.3. REAGENTS.

5.3.1. The analyzer must have the on-board ability to maintain reagents and QC material at the proper storage temperatures for the assays listed in Table A1 below. The shelf life for onboard reagent must be minimum of 220 hours for Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT), 72 hours for Fibrinogen and D-Dimer. All assays must be FDA approved.

5.3.2. The analyzer must be capable of maintaining calibration curves for all of the assays listed in Table A1 below simultaneously.

5.3.3. The assays listed in Table A1 below must be present on the analyzer at all times.

5.3.4. The assays listed in Table A1 must be approved by the FDA for plasma samples.

5.3.5. The analyzers provided must have the capability to add/change out reagents/reagent packs with only a minimal calibration/quality control requirement, i.e., must allow the user to calibrate any assay, remove the assay reagents/reagent packs for a period of undetermined time, and then reload the reagents/reagent packs to run the assay without the need for recalibration in most instances, thereby allowing the user to meet work test scheduling requirements specific to the work site.

5.3.6. The Contractor shall optimize the specific arrangement of the reagents/reagent packs for assays that are routinely maintained on the analyzer during the initial installation of the analyzer and when a new assay is added to the test menu. The Contractor must ensure that all required reagents/reagents packs are accounted for in the loading plan for the assays that are routinely maintained on the analyzer (assays to be routinely maintained on each of the analyzers to be specified at the time of installation).

5.3.7. The Contractor shall provide an estimate of the yearly quantities of reagent/reagent packs, calibrators/standards, and quality control materials required to perform the volume of tests for each assay as provided in Table A1. The Contractor shall ensure that requirements for routine quality control runs (as defined by LRMC DPALS QA program; three times daily, 365 days per year), routine calibration, periodic calibration/calibration verification (i.e., each assay must be calibrated or have calibration verification performed at intervals not to exceed a 6-month period of time), and for troubleshooting of out-of-control assays be considered when calculating the yearly requirements. The Contractor shall also estimate the volume of user-replaceable maintenance items that will be required to support the analyzer, and any analyzer specific tools/supplies necessary to perform operator-level periodic maintenance tasks, at the level of use specified in Table A1. All reagents and QC material shall conform to the published/stated specifications.

5.3.8. Reagents must have a minimum shelf life of three months upon receipt by the Government, or, if this shelf life requirement cannot be met, the Contractor must identify the guaranteed shelf life after receipt that can be accommodated in their response to the Request for Quotation (RFQ).

Table A1 – Listing of Required Assays and Annual Patient Testing Volume

(Does not include calibrators, controls or standards)

Maximum daily requirement

PT 50 in a day

APTT 45 in a day

Fibrinogen 5 in a day

D-Dimer 5 in a day

5.3.9. The manufacturer will sequester the required quality control materials and test reagents and ensure that no more than one lot change occurs per contract year.

5.3.10. All reagents provided shall be identical to those used in the FDA 510K approval application. All reagents/reagent packs shall be provided as follows:

5.3.10.1. Inclusive of an English language package insert.

5.3.10.2. Be provided by the manufacturer of the equipment.

5.3.10.3. Be marked with the required storage temperature.

5.3.10.4. Be maintained at the proper storage temperature during transportation from the Contractor’s storage facility to the Government acceptance site and be delivered on time at the appropriate storage temperature.

5.3.11. The Contractor shall provide the reagents/reagents packs, calibrators and linearity standards every 6 Months, quality control materials, user-replaceable maintenance items, and analyzer specific tools/supplies as outlined in the Schedule of Supplies/Services.

5.3.12. Deliveries of required items shall be per monthly periodic orders called in to the Contractor by the designated Contracting Officer’s Representative or others as identified in the contract. Orders shall arrive within one week of requested date of delivery.

5.3.12.1. Emergency orders shall be delivered within 24 hours after the order is placed and be of the same lot number of calibrators/standards, reagents/reagent packs, or quality control materials currently in use for the assay(s) for which supplies are being requested.

5.3.12.2. Sexual Assault Reporting. The contractor will immediately (within 24 hours) report an incident of sexual assault to the COR.

5.3.12.3. Sexual Harassment Reporting. The contractor will immediately (within 24 hours) report an incident of sexual harassment to the COR.

5.3.13. Preservation and packing - preservation and packing shall be performed in accordance with the best commercial practice and in such a manner to afford adequate protection against any damage during shipment from source to destination.

5.4. MAINTENANCE AND SERVICE

5.4.1. MAINTENANCE. The Contractor shall be responsible for furnishing maintenance, services, repairs, and parts as required in order to maintain the systems in optimal operating condition.

5.4.1.1. The Contractor is required to maintain all equipment installed under this contract except for repairs necessitated by willful damage or negligence on the part of the U.S. Government.

5.4.1.2. The Contractor shall provide all personnel, equipment, tools, materials, supervision, parts, transportation, and other items and services necessary to perform all required repairs and scheduled preventive maintenance/safety inspections and calibrations of equipment. The performance of scheduled periodic preventive maintenance, safety checks, and calibrations that are not normally performed at the operator level shall be performed by Contractor service personnel in accordance with requirements as specified in the Contractor’s instrument maintenance manual. Completion of installation of the analyzers shall establish time zero for determination of time frames for performance of the above periodic services.

The Contractor shall provide a full unscheduled and preventive maintenance service for the lease period at no additional cost. Service shall include repair and replacement of defective parts, complete maintenance program (as required by the manufacturer’s maintenance manuals), and hotline telephone service, to assist operators in troubleshooting problems in accordance with paragraph 5.4.2.1 of this Performance Work Statement.

5.4.1.3 REPAIR: Upon notification of equipment failure, the Contractor shall respond to telephonic requests for unscheduled repair within one (1) working day for all sites. Should both machines at LRMC become inoperable, the Contractor’s technical specialist must be on-site within four (4) hours of initial notification. If the equipment cannot be repaired, a replacement instrument shall be provided within 72 hours. The Contractor shall provide replacement parts as necessary for operator level maintenance.

5.4.1.4 All work shall be performed in a professional manner by an authorized service representative. If any deficiencies are found due to negligence of the service representative, the Contractor shall be required to correct the deficiency to a fully operational status in accordance with manufacturer specifications at no additional cost to the U.S. Government.

5.4.1.5 All correspondence, service reports, and invoicing shall be in English.

5.4.1.6 Preventive maintenance services shall be performed in accordance with the manufacturer’s standards/procedures. A preventive maintenance service shall include, but is not limited to, safety, calibration, complete operational testing, lubrication, adjustments, and cleaning of equipment to which the operator does not have access. This also includes the installation of all non-operator parts required to ensure proper operation.

5.4.1.7. The Contractor shall notify the Point of Contact of the exact date and time for performance of a preventive maintenance service within ten (10) days prior to the scheduled preventive maintenance services.

5.4.1.8. Tobacco use is prohibited within Landstuhl Regional Medical Center and its clinics.

5.4.1.9. Prior to performing Scheduled Maintenance and Unscheduled Repair Services work, the Contractor's representative shall report to and obtain from the Equipment Management Branch, (LRMC, Building 3760, Ward 4B) a Visitors Badge. The badge must be returned to the Equipment Management Branch prior to departing LRMC.

5.4.1.10. Within one (1) working day after completion of a repair, the Contractor’s representative shall furnish the Point of Contact (POC) one (1) copy of a service report for all services performed. The service report shall be in English and shall contain, as a minimum, the following information:

5.4.1.10.1. Nomenclature and serial number

5.4.1.10.2. Date

5.4.1.10.3. Description of services performed (i.e., preventive maintenance service, or unscheduled repair service)

5.4.1.10.4. Location of services performed

5.4.1.10.5. Duration of performance (hours)

5.4.1.10.6. List of parts replaced or other actions taken to restore operability of the instrument

5.4.1.10.7. Name of technician

5.4.1.10.8. The Contractor representative shall submit the service report to:

Landstuhl Regional Medical Center

Chief, Equipment Management Branch

BLDG 3760, Ward 4B

66849 Landstuhl

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

5.4.1.12. When required, the Contractor shall comply with the Occupational Safety and Health Administration lockout and tagout procedures while performing maintenance on electrical equipment.

5.4.1.13. Safety Inspections shall be performed at least annually in accordance with NFPA 99, Chapter 7. This regulation can be reviewed in full text at the Equipment Management Branch.

5.4.1.14. Preventive maintenance inspections and calibrations must be performed in accordance with Contractor’s guidance as specified in the Contractor’s instrument maintenance manual.

5.4.1.15. When appropriate, the Contractor’s representative shall attach and complete a DD Form 2163 (sticker), entitled “Medical Equipment Verification/Certification” to the equipment upon completion of calibration services. The Point of Contact will provide the DD Form 2163 to the Contractors’ representative. If the DD Form 2163 is already attached to the equipment, the Contractors' representative shall update the existing DD Form 2163. Procedures for updating the 2163 will be provided by the Point of Contact.

5.4.2. SERVICE:

5.4.2.1. The Contractor shall provide same day customer service and support, Monday to Friday from 0800 to 1700, as stated under paragraph 1.6.2.

5.4.2.2. The Contractor shall perform Preventive Maintenance Services (PMS), safety tests, calibrations, and unscheduled repair services in accordance with procedures and practices prescribed by the manufacturer of the equipment.

5.4.2.3. The Contractor shall provide a full unscheduled and Preventive Maintenance Service for the lease period. The lease agreement shall be inclusive of all costs for the performance of scheduled periodic maintenance (as required by the Contractor’s instrument maintenance manuals), unscheduled maintenance and repair of the analyzers and any associated equipment provided by the Contractor as part of the analyzer system, including replacement parts, replacement part shipment costs, and service technician travel costs for performance of maintenance services.

5.4.2.4. Scheduled routine services shall be performed between 0730-1630 Monday-Friday, excluding German and American Holidays.

5.4.2.5. The Contractor’s qualified service technician shall be on site to provide routine services; service requiring immediate repair; and one (1), two (2) or four (4) scheduled services for preventive maintenance (as specified in the Contractor’s instrument maintenance manual), safety and calibration as required by this statement of work. The equipment shall be repaired and operational within 48 hours after initial response by the Contractor.

5.4.2.6. Upon analyzer failure between 0730-1630 Monday-Friday, the Contractor’s qualified service technician shall be on-site to provide unlimited emergency service (service requiring immediate repair; an unscheduled maintenance/service requirement) within 24 hours. The equipment shall be repaired and operational within 48 hours after initial response by the Contractor.

5.4.2.7. Emergency Services and unscheduled services outside regular working hours, on weekends, and on German Holidays. The Contractor’s qualified service technician shall be on-site to provide unlimited emergency service (service requiring immediate repair) within 24 hours. The equipment shall be repaired and operational within 72 hours after initial response by the Contractor.

5.4.2.8. Should both analyzers at LRMC become inoperable, the Contractor’s technical repair specialist must be on-site within four (4) hours of initial notification and the repair of at least one (1) instrument completed within one (1) working day of initial notification. If deemed necessary after consultation with the Contractor, if at least one analyzer cannot be repaired within one (1) working day of the initial notification, a replacement analyzer, at no additional cost to the U. S. Government, will be provided within 72 hours of the initial notification to be utilized by the Government until the original instrument is fully repaired and accepted for service. During the period when both analyzers are inoperable, the Contractor shall arrange the pickup and delivery of critical specimens to a College of American Pathologists accredited clinical laboratory of their choice within Germany. The selected laboratory must provide patient reports in English. Each patient report must include the testing laboratory’s reference range for the test being performed. The Contractor shall pay all costs associated with the provision of this service, including those for delivery of hardcopy patient results by DHL or other express courier, for as long as both analyzers remain inoperable.

5.4.2.9. If the equipment is out of service for longer than 48 hours (from the time of service technician’s arrival on site), the Contractor shall notify the Chief, Clinical Engineering Branch, in writing as to the reason(s) (i.e. non-availability of parts, etc.) for non-compliance.

5.4.2.10. The Contractor shall provide all necessary user-replaceable maintenance items that will be required to support the analyzer, and any analyzer specific tools/supplies necessary to perform operator-level periodic maintenance tasks, at no additional cost to the Government.

5.4.2.11. The U.S. Government will make the equipment available to the Contractor for servicing at such time and duration necessary to perform needed repairs.

5.5. TRAINING:

5.5.1. The Contractor shall provide initial on-site operator training (about 35 Persons) to all technicians assigned to the Government site during the first year. Training in subsequent years will be dependent upon turn-over of personnel within the section, (i.e., LRMC Dept of Pathology Core Laboratory staff) prior to initiation of use of the analyzer for patient testing.

5.5.2. In addition, the Contractor shall provide training for two (2) primary operators per analyzer , at the Contractor’s training site, prior to delivery and installation of the analyzers, and shall provide two additional training slots per analyzer for each contract option year. This training shall be at no additional cost to the Government and shall encompass basic operation, maintenance, troubleshooting and software training. The contractor is responsible for all applicable transportations costs (public and private), lodging, and meal costs for the trainees. Travel costs shall not exceed the current JTR/JFTR. Travel benefits shall be provided in-kind (rather than in cash).

5.5.3. The Contractor shall provide on-site training for 8 technicians annually at no cost to the Government or individual trainee.

5.5.4. All training manuals/guides, instructional literature, and any other related written/electronic material shall be in the English language. Training shall include basic operation of the analyzers, trouble shooting procedures, performance of operator-level periodic preventive maintenance procedures, and use of the data management/quality control software.

5.6. DELIVERY OF EQUIPMENT:

5.6.1. The Analyzers must be delivered to the location as indicated below within (2)-two weeks after contract award. Equipment setup, on-site training, method validation studies, and analytical measurement range/linearity verification, must be completed by vendor personnel within a period of time to ensure that equipment is fully operational on 30 NOV 2016 During the initial implementation, an English-speaking technical representative must be available telephonically 24 hours/ 7 days a week.

5.6.2.

LOCATIONS OF COMPLETE SYSTEMS:

5.6.2.1.

Landstuhl Regional medical Center (LRMC):

Two (2) systems shall be delivered and installed at:

Landstuhl Regional Medical Center

Department of Pathology

Building 3711, Room F203

66849 Landstuhl, Germany

5.6.2.2.

Exact installation locations at the hospitals shall be coordinated by the Contractor with the point of contacts listed below:

NCOIC, Hematology

Core Laboratory

Department of Pathology and Area Laboratory Services

Tel: 06371-86-8007; DSN: 314-486-8007

5.7. DELIVERABLES

5.7.1. Sexual Assault…