Amendment 0001.pdf

W91YTZ20Q0234

W40M RHCO-ATLANTIC USAHCA

NORTHERN REG CONTR OFC NRCO

POC: REBECA-LYNN.M. RUFF

P-11050 MT BELVEDERE BLVD

FORT DRUM NY 13602

0011498831

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 revise PWS paragraphs 5.3.5, 5.8, 5.1.6. and to add the Salient Characteristics. All other terms and conditions remain the same.

1. CONTRACT ID CODE PAGE OF PAGES

J 1 28

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

16C. DATE SIGNED

BY 19-Aug-2020

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 W91YTZ20Q0234

X 9B. DATED (SEE ITEM 11)

11-Aug-2020

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

19-Aug-2020

CODE

W40M RHCO-ATLANTIC USAHCA

NORTHERN REG CONTR OFC NRCO

6021 5TH ST BLDG 1467

FORT BELVOIR VA 22060-5580

W91YTZ 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE W91YTZ

FACILITY CODECODE

EMAIL:TEL:

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 20-Aug-2020 04:00 PM to 25-Aug-2020 04:00 PM.

The following have been added by full text:

PWS

PERFORMANCE

WORK

STATEMENT

FOR

URINE

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 one leased urinalysis systems for USA MEDDAC Fort Eustis, VA systems (Iricell Analyzer System supporting McDonald-Eustis. Contractor will provide the instruments, ancillary equipment, maintenance, services, repairs, support, parts and training as required to maintain the systems in optimal operating condition and any installation and removal, at no extra cost to the Government).

Analyzer will be located on the first floor, Pathology Laboratory MCAHC, BLDG 576 Fort Eustis, VA, 23604. Service shall include installation, correlation/method comparison, preventive maintenance, and all troubleshooting. Funding will be allocated annually subject to the availability of funds. The contractor shall perform to the standards of this performance work statement.

1.2 NON-PERSONAL SERVICES: For the period 01 October 2020

through 30 September 2025, the contractor shall provide all personnel, equipment, tools, materials, supervision, parts, transportation, and other items and services necessary to perform all required repairs and two (2) preventive maintenance (PM), and one (1) safety (ST) service/ inspection on leased analyzer. The contractor shall furnish a detailed listing of any replacement parts provided under the terms of this contract. This listing shall contain the part number, nomenclature, normal life expectancy and price, and shall indicate whether the item is an exchange part. Services to be performed include all unscheduled routine service calls and all emergency service visits as required for all Line Items. All parts provided by the contractor shall be covered by the terms and conditions of the contract. All work shall be performed in a professional manner by qualified, authorized service representative(s). 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.

1.3 PERIOD OF PERFORMANCE:

Base Year: 1 October 2020 – 30 September 2021 Option Year 1: 1 October 2021 – 30 September 2022 Option Year 2: 1 October 2022 – 30 September 2023 Option Year 3: 1 October 2023 – 30 September 2024 Option Year 4: 1 October 2024 – 30 September 2025

1.2. PERSONNEL

1.2.1. 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. Neither uniformed personnel nor Government civilian

employees shall be employed to perform services under this contract.

1.2.3. 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.

1.2.3.1. 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.

1.2.3.2. The contract manager or alternate shall be available 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, the manager or alternate shall be available within 48 hours.

1.2.3.3 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.

1.2.3.3. The contractor shall not employ any person who is an employee of the US 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.

1.2.5. 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.

1.2.6. Employee Training. All contractual agreed training will be furnished by the contractor at no additional cost to the government. Additional required training will be paid separately

1.3. QUALIFICATIONS.

1.3.1. 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 Hospital representatives.

1.3.2. 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.

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, 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 nonoccurrence shall be provided in writing to the contracting officer within 10 calendar days following receipt of the minutes.

1.5. ADMINISTRATIVE.

1.5.1. Security.

1.5.1.1. Contractors shall be signed into military installations by authorized personnel only.

1.5.2. Training. The contractor shall be permitted to participate in U.S. Army training activities as deemed appropriate by the Commander, McDonald Army Health Center. Attendance at such training will be at no cost to the Government.

1.5.3. Physical Security. The contractor shall safeguard all Government property provided for the contractors use. At the close of each work period, Government facilities, equipment, and materials shall be secured.

1.5.3.1 Key Control. Under normal circumstances, no keys will be issued to the contractor. In the event that a key or keys are issued, the contractor shall ensure that all such keys are not lost or misplaced and are not used by unauthorized persons. The contractor shall assure that keys issued by the Government are not duplicated.

1.5.3.1.1. The contractor shall report lost or duplicated keys to the COR.

1.5.3.1.2. If keys other than master keys are lost or duplicated, the Contracting Officer may require the contractor to re-key or replace the affected lock or locks. If the Contracting Officer decides to replace the affected lock or locks, the total cost to the Government shall be deducted from payment due the contractor. If a master key is lost or duplicated, all locks and keys for that system shall be replaced by the Government and the total cost deducted from payment due thecontractor.

1.5.3.1.3. The contractor shall not permit unauthorized person(s) entry to the installation nor any facilities.

1.5.3.1.4 The contractor shall ensure that lock combinations are not revealed to any unauthorized person(s).

1.5.4. Conservation of Utilities. The contractor shall observe energy conservation policies, to include:

1.54.1. Lights shall be used only in areas where and when work is actually being performed.

1.5.4.2. Water faucets or valves shall be turned off after use.

1.5.5. Vehicle Operation, Registration and Insurance. The contractor will comply with the local installation requirements for vehicle registration. Any vehicle operated in performance of this contract must have appropriate liability coverage.

1.6. HOURS OFPERFORMANCE:

1.6.1. ROUTINE/EMERGENCY SERVICE:

1.6.1.1. Normal Hours of Operation. The contractor shall provide unlimited routine/emergency service during normal work days. Monday through Friday, between 0800-1630 hours.

1.6.1.2. Holidays. Routine services and reagent delivery will not be required on standard US Federal Holidays.

If an emergency arises, services and reagent delivery will be rendered between the hours of 0800 - 1200.

1.6.2. The Contractor shall provide direct customer service and support, M-F as outlined in 1.6.1.2, to include hotline telephone service to assist operators in correcting equipment operation problems. A technically qualified person will be available at all times.

1.6.3 RESERVED.

1.6.4. The contractor's qualified service technician shall be on site to provide routine services, service requiring immediate repair, and two (2) scheduled services for preventive maintenance, safety and calibration as required by this performance work statement.

1.6.4.l The contractor's qualified service technician shall respond telephonically within two hours and shall be on site to provide unlimited emergency service (service requiring immediate repair) within 24 hours.

1.6.4.2. 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, Medical Maintenance Division, in writing as to the reason(s) (i.e. non- availability of parts, etc.) for non-compliance with the terms of this contract. The contractor shall then provide, at no additional cost to the U.S. government, a substitute piece of equipment to be utilized by the government until the original equipment is fully repaired and accepted forservice.

1.6.4.3 The U.S. government will make the equipment available to the contractor for servicing at such time and duration necessary to perform needed repairs.

1.6.5. Holidays.

1.6.5.1. The following is a list of legal US Federal holidays as referred to elsewhere inthe contract.

New Year's Day, January 1st Martin Luther King's Birthday, 3rd Monday in January President's Day, 3rd Monday in February Memorial Day, Last Monday in May Independence Day, July 4th Labor Day, 1st Monday in September Columbus Day, 2nd Monday in October Veteran's Day, November 11th Thanksgiving Day, 4th Thursday in November Christmas Day, December 25th

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.

1.7. CONDUCT.

1.7.1. Contractor personnel shall comply with MTF policies regarding personal appearance and conduct.

1.7.2. Impaired contractor personnel: At any time during the performance of this contract, the Contracting Officer, COR, or Commander of the MTF may direct the contractor to immediately remove any contractor employee whose actions or impaired state raises reasonable suspicion that clear and present danger of physical harm exists to a patient, government personnel and equipment or to the impaired individual. This provision will be used in emergency situations only and not for the purpose of bringing performance issues or other non-urgent concerns to the attention of thecontractor.

2. DEFINITIONS/ACRONYMS.

2.1. DEFINITIONS. Following is a list of basic PWS 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, TJC, 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).

2.1.7 DOWN TIME: A laboratory term which is a special alert control referring to when active operations of computer information systems, power shortages or even equipment failure has caused limited or no ability for testing to be accomplished.

2.2. ACRONYMS/ABBREVIATIONS. Following is a list of basic

acronyms/abbreviations used in the contract.

COR

eve

DA

JCAH

O

CAP

DA

DoD

CLIP

HIPAA

TJC

OSHA

QA

QA&I

QC

MCAC

Contracting Officer's Representative Calibration, verification, or certification Department of the Army Joint Commission on Accreditation of Healthcare Organizations College of American Pathologists Department of the Army Department of Defense Clinical Laboratory Improvement Program Health Insurance Portability & Accountability Act of 1996 The Joint Commission Occupational Safety and Health Administration Quality Assurance Quality Assessment & Improvement Quality Control McDonald Army Health Center

3. GOVERNMENT FURNISHED FACILITIES, EQUIPMENT, SERVICES,

MATERIAL, UTILITIES, AND EMERGENCY HEALTHCARE.

3.1. FACILITIES. No government facilities will be provided.

3.2. EQUIPMENT. No government furnished equipment will be provided.

3.3. SERVICES. No government services will be provided.

3.4. MATERIAL. No government furnished equipment will be provided.

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

3.6. Use of Military Class C telephone. Personal long distance calls are not authorized and the cost of all personal long distance calls made will be deducted from the contractor's invoice.

3.7. 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.

4. CONTRACTOR FURNISHEDSUPPLIES/SERVICES:

4.1. Uniforms. Contractor shall ensure all contractor personnel wear clothing that clearly distinguishes the individual as contract personnel.

4.2. Nametags. The contractor shall furnish a nametag for each contract employee. The nametag will contain the name of the company and the employee.

4.3 The contractor will furnish all supplies/services required in the performance of this contract except those listed in paragraph 3 above.

5. SPECIFIC TASKS:

5.1. DESCRIPTION: The contractor shall provide on-site technical support for installation of analyzers to bring the system to a fully operational status at MCAHC.

5.1.1 Contractors must coordinate and conduct a site visit to the MCAHC Department of Pathology, building 576, 1st Floor for the purpose of surveying and assessing current laboratory set-up, laboratory environmental control, and available utilities with regard to placement of their instrument 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 instrument must be identified in the Contractor's proposal/quote (i.e., must identify all site preparation requirements necessary for potential placement of their instrument 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 method (comparison of method study), validation of analytical measurement range (AMR), validation of precision (replication study) and accuracy (recovery study), and establishment of initial control ranges using contactor supplied controls. All reagents, calibrators and linearity materials will be provided by the contractor.

5.1.3 The Contractor will 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) and MHS Genesis. The Contractor must have an established driver compatible for interfacing the analyzer with the CHCS and MHS Genesis. The interface between the LIS and the analyzer must be bi-directional.

5.1.5 The analyzer will have a Data Management system that provides on-line Levy-Jennings graphs and applies Westgard Quality Control Rules as selected by the user and delta checks. Also required is 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 peergroup.

5.1.6 The Contractor shall provide material safety data sheets (MSDS) and/or 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 MSDS/SDS shall contain information on the hazards associated with each specific chemical or material. The MSDS/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 will 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 will be done by a schedule approved by MCAHC

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

5.1.10 The completion of the initial correlation validation studies to include the completion of the Heparin Curve.

5.2. Non-personal service to include, but not limited to, providing all personnel, equipment, tools, supervision and other items necessary to maintain medical equipment as listed on the equipment list (Attachment 2).

5.2.1. The contractor's representative shall perform preventive maintenance inspections (PMI), calibrations and unscheduled repair services in accordance with procedures and practices prescribed by the manufacturer of the equipment.

5.2.2. The contractor shall maintain the equipment listed below in proper operating condition as described in the manufacture's literature. The contractor shall provide: One safety test and preventive maintenance service to be performed every six months and all unscheduled routine and all emergency services as required. The scheduled preventive maintenance shall include written documentation of servicing, cleaning, lubrication, adjustments, and operational tests in accordance with manufacturer's specification and all applicable government and Army regulations.

5.2.3. Preventive maintenance shall include the exchange of defective parts and modules, a complete inspection, cleaning, and preventive maintenance of the unit, the exchange of missing or defective covers, lamps, and keys, an inspection or repair of cables, plugs, and wiring, a thorough function test of the input- and safety circuits, checking the topicality of the operator manuals, and information and training of new personnel. The safety inspection shall include a mechanical check (examination of the casing, the readings, user interfaces, connections, cables, labeling, soiling which would affect safety, etc.), a function test, as services include written documentation of servicing, cleaning, lubrication, adjustments, operational tests, and calibration/verification in accordance with the manufacturer's specifications and all applicable U.S. government and Army regulations.

5.2.4. All preventive maintenance inspections/verifications/calibrations shall be performed in accordance with the manufacture's service manual, which will be located with the equipment, or provided by the contractor.

5.2.5. In accordance with MEDCOM directives and extracted from TB 38-750-2, the contractor performing the calibration, verification, or certification (CVC) action will complete a Field Service report within 24 hours of completion of services.

5.2.5.1. The Field Service Report entries will be legibly made with a blue, blue-black, or black ballpoint pen. It is acceptable for the report to be e-mailed also. The following information must be included:

5.2.5.2. 1 ID NUMBER. Enter the ID number of the equipment assigned by the government.

5.2.5.3. 2 MODEL NO. Enter the model number of the equipment as assigned by the manufacturer.

5.2.5.4. 3 SERIAL NUMBER. Enter the serial number assigned to the equipment by the manufacturer.

5.2.5.5. 4 AUTHORITY. Enter the authority authorizing the CVC. If unsure of the authorizing authority, seek guidance from Clinical Engineering Branch personal.

5.2.5.6. UIC. Enter the name of the company with whom the contractor is affiliated.

5.2.5.7. CERTIFIED BY. Enter the initials of the person performing the CVC.

5.2.5.8. DATE COMPLETE. Enter the calendar date (MMM/YY) on which the CVC was completed.

5.2.5.9. DATE DUE. Enter the calendar date (MMMNY) on which the next CVC procedure is due.

5.2.6.1. System damage due to non-performance of routine maintenance procedures or improper handling by the customer is not covered by the contract unless it is modified to include such repairs. Accessories and manuals are not covered under the contract. If the contractor finds that damage is due to improper handling or non-performance of routine maintenance procedures, the contractor's representative shall within one (1) working day report the extent of the damage and submit a cost estimate for the repair work to the Chief, Medical Maintenance Division. The repair shall not be performed without a written modification to this contract or a purchase order authorizing such repair. The Chief, Medical Maintenance Division will review the estimate and submit a separate repair request (as processed to include the funding) to the Administering Contracting Officer, in order that the contract can be modified or another purchase order issued to authorize such repair.

5.2.6.2. The contractor shall only accept calls for service/repairs from the Chief, Medical Maintenance Division, or his/her authorized designated representative, as listed in Attachment 2.

5.2.6.3. Prior to, and upon completion of any scheduled or unscheduled service, the contractor service representative must report to the Chief, Medical Maintenance Division, or his/her designated representative at.

McDonald Army Health Clinic Laboratory Bldg.576 Fort Eustis Virginia 23604 Tel. (757)3147972

5.2.6.4. On the day services (scheduled and/or unscheduled) are completed, the contractor's service technician shall prepare and initial, legible service report, and present it to the Chief, Medical Maintenance Division, or his/her designated representative for signature. This report shall include the followinginformation:

(1) Services performed

(2) What systems or components failed (reason for call)

(3) Start date/time

(4) Completion date/time

(5) Name of service technician

(6) Part numbers, quantities, and prices of replaced parts

(7) Travel time

(8) Repair time

(9) Travel, repair and parts cost

5.2.6.5. In the event that all the necessary information is not available to the service technician at the time of completion of service, the initial service report shall include all information available. The contractor shall provide/fax the remainder of the required information to:

Attn: Chief, Medical Maintenance Division McDonald Army Health Clinic Building 576 Fort Eustis, Virginia 23604 within 10 days after completion of service

5.2.6.6. The contractor must obtain authorization from the Chief, Medical Maintenance Division, or his/her authorized representative, prior to starting any repair that is attributable to instrument abuse, and/or instrument misuse, theft, neglect, fire, and anything else not covered in this contract.

If these types of repairs are performed without the prior approval of the Chief, Medical Maintenance Division or his/her designated representative; the contractor shall not be paid by the U.S. government. If approved, a separate purchase order shall be issued prior to performance.

5.3 ANALYZER.

5.3.1. The analyzer must provide all required Urinalysis 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, 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.

5.3.2. The analyzer system will provide users with rapid, reliable test results that are critical for patient care. The analyzer system 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.

5.3.3. The system will come equipped to perform continuous, random and statistical analysis;

capable of real time or (on-line) Quality Control. Provide QC assessment with comparison to a peer group on a daily, weekly, and monthly basis, to include QC Lot#s, means, ranges, SD, and %CVs. Changing or modifying existing QC parameters can be performed during instrument operation (e.g. “on-the-fly”).

5.3.4. The system must have positive patient identification via on-board barcode scanner.

5.3.5. The system at MCAHC must be a fully-automated, integrated urine chemistry and urine microscopy analysis system. Chemistry analysis must include detection of bilirubin, urobilinogen, ketones, ascorbic acid, glucose, protein, blood, pH, nitrites, leukocytes, and specific gravity.

5.3.6. The microscopic capabilities at MCAHC must include quantitative detection of all formed sediment elements in urine, including RBCs, WBCs, SECs, bacteria, yeast, mucus, crystals, spermatozoa, and casts.

5.3.7. The system must be able to identify and flag samples with interfering substances. It must send flags and levels to the LIS or data management system.

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

5.3.9. The analyzer systems must come equipped with an un-interruptible power supply capable of providing all necessary electrical power to each analyzer system, to include the data management system, for 15 to 20minutes.

5.3.10. The analyzer systems and all reagents shall be FDA approved. The analyzer and associated parts and accessories will be new. No used, refurbished, or like-new equipment are authorized in support of this contract.

5.4 REAGENTS

5.4.l. The Contractor shall provide an estimate of the yearly quantities of reagent, calibrators/standards, and quality control materials required to perform the volume of tests for each assay as outlined in the supplied quote of Urinalysis Annual Tests. The Contractor will ensure that requirements for routine quality control runs (as defined by MCAHC QA program), routine calibration, periodic calibration/ calibration verification, and for troubleshooting of out-of-control assays be considered when calculating the yearly requirements. The Contractor will 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.

5.4.2 The manufacturer will sequester the required quality control materials and test reagents and ensure that no more than one lot change occurs every 12 months.

5.4.3. Be provided by the manufacturer of the equipment.

5.4.4. Be marked with the required storage temperature.

5.4.5. 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.

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

5.4.7. Deliveries of required items will 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 will arrive within one week of requested date of delivery.

5.4.8. Emergency orders will 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 beingrequested.

5.4.8.1. 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.

5.5. THE USE OF CELLULAR PHONES AND 2-WAY RADIOS: Cellular phones and 2-way radios will not be used in prohibited areas as posted.

5.6. RECEIPT OFSERVICES:

5.6.1. Receipt of services will be acknowledged after receipt of all complete service reports for any scheduled calibration, preventive maintenance and unscheduled routine and emergency services performed during the respective quarter. Receiving reports will not be prepared and submitted until all such completed service reports containing all required information are in the possession of the Chief, Medical Maintenance Division or his/her designated representative.

Services to be acknowledged by, service reports and invoices sent to:

Chief, Medical Maintenance Division Tel: (757) 314-7828

5.6.2. Job Site Location. Main Lab, McDonald Army Health Center, Fort Eustis.

5.6.3. Work Conditions.

5.6.4. Preventive maintenance inspection and safety testing must be performed semi-annually as indicated in Paragraph 1.1.

5.6.5. The contractor shall notify the COR (Contracting Officer Representative) of the exact date and time within

(10) days prior to the scheduled preventive maintenance services.

5.6.6. All unscheduled repairs shall be verified by a MER (Medical Equipment Repairer) prior to notification of the contractor by theCOR.

5.6.7. The contractor shall respond to unscheduled repair service calls from the COR telephonically within two hours, Monday through Friday between the hours of0800 and 1630 excluding local national holidays. Unscheduled repair service calls shall be accepted only from the COR.

5.6.8. Completion of Unscheduled Repairs. The contractor's technician must be on site and commence repair services within 24 hours.

5.6.9. Replacement Parts.

5.6.9.1. All replacement parts shall be certified, new and have the same material as the original part. The original design of the equipment shall not be changed, modified or the required functional capacities altered. Certified parts are parts that comply with the standards set forth in 21 CFR 1020.30 (applicable to radiation producing equipment only), installation in medical equipment. This regulation can be reviewed in full context at the Medical Maintenance Division.

5.6.9.2. In place of new parts, factory refurbished exchange parts as per spare parts policies and procedures may be used. The contractor's representative shall inform the COR and request his / her approval prior of the use of a refurbished part.

5.6.9.3 Smoking is prohibited within the U.S. Army Medical Department Activity, Fort Eustis, and its clinics.

5.6.9.4. Prior to performing work the contractor's representative shall report to the Medical Maintenance Division (Building 576). Repairs that cannot be performed at the Government site may be performed at the contractor's site provided the COR approves removal of the equipment.

The contractor's representative shall sign a receipt for the equipment. The repaired equipment shall be returned to the original premises within two (2) working days, or the contractor shall provide a temporary replacement at no additional cost to the government.

5.6.9.5. The contractor shall complete a Field Service Report to include the manufacturer, model, serial number, and date of calibration, expiration of all items of test and measurement equipment used to perform the calibration. Required forms and extracts from pertinent directives will be furnished to the contractor by the government in accordance with regulation TB 38-750-

2. Full text version of TB 38-750-2 will be made available by the authorized COR upon request.

5.6.9.6. Within one (1) working day after completion of repair, the contractor's representative shall furnish the COR one (I) 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:

- Nomenclature and serial number.

- Date.

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

- Location of services performed.

- Duration of performance (hours) and labor rate.

- List of parts replaced and cost of each part.

- Travel hours and travel rate.

- Name of technician

5.6.9.7. In the event that pricing data is not available to the contractor's representative, he/she shall provide the information required in Paragraph 5.9.1 above without the labor / travel rate and parts cost. The contractor's representative shall, however submit the pricing data not later than five (5) working days after completion of services to:

McDonald Army Health Clinic Laboratory Bldg. 576 Fort Eustis Virginia 23604 Tel. (757)314-7972

5.6.9.8. Preventive Maintenance Inspection.

5.6.9.8.0 Preventive maintenance inspections shall be performed in accordance with the manufacturer's standards/procedures. The preventive maintenance inspection shall include, but is not limited to safety, 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.

5.6.9.8.1 Safety testing shall be performed in accordance with NFPA 99, Chapter 7. This regulation can be reviewed in full text at the Medical Maintenance Division.

5.7 The contractor's representative shall complete a Field Service Report upon completion of calibration services. The Field Service Report will be provided to the contractors' representative by the POC.

5.8. MATERIAL SAFETY DATA SHEETS (MSDS)/Safety Data Sheets (SDS):

The contractor shall provide MSDS/SDS for each item delivered under this contract that is considered to be HAZARDOUS MATERIAL by its representative government. The MSDS/SDS shall contain information on the hazards associated with each specific chemical or material.

The MSDS/SDS shall be printed in the English language and shall contain as a minimum the following information: identification of the specific hazard, the required practice 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.

5.9. APPLICABLE TECHNICAL ORDERS, SPECIFICATIONS, REGULATIONS, AND MANUALS.

5.9.l. GENERAL. Contractor will comply with all U.S. laws pertaining to medical equipment FDA Approved. Contractor will also comply with all Department of Defense (DOD), Department of Army (DA), US Army Medical Command (USAMEDCOM), and IRACH regulations and policies pertaining to medical equipment. Current issues of many DA publications can be accessed at http://www.usapa.army.mil/gils. Current issues of many forms can be accessed at http://www.usapa.army.mil/forms. Publications and forms not on the internet can be obtained from the MTF. These regulations include, but are not limited to, the following:

5.9.2. The Publications have been coded as mandatory or advisory. The contractor is obligated to follow those coded as mandatory only to the extent that they apply to this contract. Supplements, amendments, or changes to these mandatory publications may be issued during the life of the contract. Advisory publications may be used for information and guidance but are not binding for compliance.

6.0. Publications:

6.0.1. Mandatory:

Public Law 91-596 29 Dec 70 Occupational Safety and Health Administration Public Law 104-191 (Aug 1996) Health Insurance Portability and Accountability Act of 1996 Current Edition The Joint Commission (TJC)

Manual AR40-l

AR40-2

AR40-4

AR40-

68 AR

380-19

Composition, Mission, and Functions of the Army Medical Department Army Medical Treatment Facilities and General Administration Army Medical Department Facilities/Activities Quality Assurance Administration Information Systems Security

CLMS PAMPHLET 40-24; Clinical Laboratory Improvement Program (CLIP) policy mandated by DODI 6440.2 NFPA 99, Chapter 7.

6.0.2. Adviso

ry AR 310- MEDCOM Pam 25-31

Dictionary of United States Army Terms Index of Command Administrative Publications (15 AUG 01)

6.1. 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.

6.2. APPLICABLE TECHNICAL ORDERS, SPECIFICATIONS, REGULATIONS, AND MANUALS.

6.2.1. Following is a list of basic publications applicable to this contract. Current issues of many DA publications can be accessed at http://www.usapa.army.mil/gils. Current issues of many forms can be accessed at http://www.usapa.army.mil/forms. Publications and forms not on the internet can be obtained from the MTF.

6.2.2. The Publications have been coded as mandatory or advisory. The contractor is obligated to follow those coded as mandatory only to the extent that they apply to this contract. Supplements, amendments, or changes to these mandatory publications may be issued during the life of the contract. Advisory publications may be used for information and guidance but are not binding for compliance.

6.2.3. Publications:

6.2.4. Mandatory:

Public Law 91-596 (29 Dec 70) Occupational Safety and Health Administration Public Law 104-191 (21 Aug 96) Health Insurance Portability and Accountability Act of 1996 The Joint Commission for Accreditation of Healthcare Organizations (JCAHO) Manual AR 40-1 Composition, Mission, and Functions of the Army Medical Department AR 40-4 Army Medical Department Facilities/ Activities

AR40-5

AR40-

AR40-

562 AR

380-19

AR 380-

AR385-

Preventive Medicine Quality Assurance Administration Immunizations and Chemoprophylaxis Information Systems Security The Department of the Army Personnel Security Program Accident Reporting and Records and HSC Supplements

6.2.5. Advisory:

AR310-25

MEDCOM Pam 25-31

Dictionary of United States Army Terms Index of Command Administrative Publications (15 AUG 01)

(End Performance Work Statement)

TECHNICAL EXHIBIT 1

PERFORMANCE

REQUIREMENTS SUMMARY

SAMPLING GUIDE

PATHOLOGY LABORATORY

MCDONALD ARMY HEALTH CENTER

FORT EUSTIS, VIRGINIA

1. The purpose of this section isto:

a. List the contract requirements considered most critical to acceptable contract performance.

b. Show the maximum allowable degree of deviation from perfect performance for each requirement or

Minimum Acceptable Standards (MAS) that shall be allowed by the Government before contract performance is considered unsatisfactory.

c. Explain the Quality Assurance methods the Government will use to evaluate the Contractor's performance in meeting the contract requirements.

d. Show the percentage of the major elements of the contract price that each contract requirement item listed represents.

e. Define the procedure the Government shall use in reducing the Contractor's monthly payment if satisfactory performance is not rendered by the Contractor.

2. The Government's primary quality assurance procedures are based on variability seen in short- and long-term quality control performance (accuracy and precision of instrument performance), shelf life of reagents (whether the reagents are supplied with the requisite shelf life remaining and whether reagent performance is stable up to the advertised expiration date), stability of test calibrations (whether excessive re-calibrations are required), reproducibility of Analytic Measurement Range at 6 month intervals, proficiency test performance, frequency and duration of instrument downtime, Contractor response to requests for assistance/repair of the instruments, and customer complaints.

3. Criteria for acceptable and unacceptable performance will be based on the MAS for each contract requirement.

When the number of defects in the Contractor's performance which are discovered by the COR exceeds the unacceptable level, the Contracting Officer shall be required to complete a CDR. The CDR requires the Contractor to explain, in writing, why performance was unacceptable, how performance will be returned to acceptable levels and how recurrence of the problem will be prevented in the future.

4. Monthly payments to the Contractor shall be reduced for unsatisfactory performance using the following methods:

a. Each month, contractor performance will be compared to contract standards and MAS's using the Government Quality Assurance Surveillance Plan.

b. If the performance in any required service is unsatisfactory and the poor performance is clearly the fault of the

Contractor, any amount of money up to the percentage cost of service, as stated in the fifth column of the Performance Requirements Summary shall be withheld.

c. Monetary deductions for unsatisfactoryperformance will be computed as follows: Example

IF: Packaging is unsatisfactory (MAS of 4.0%) AND: Monthly price is $ _

AND: Packaging work deduct percentage is 5.0%.

AND: Sample size is _ _ AND: Number of defects in samples is _ _ (reject numberis _) .

THEN: Deduction from the current month's invoice is:

Contract Price $ x Deduct Percentage 5%

TOTAL

x Percent of $ Sample Defective Deduction $

4. Performance/Quality Standards for the Urine Analyzer:

The MAS for specific analyte standards required of the Contractor are derived from the Federally mandated DoD CLIP and CLIA '03 Pamphlet 40-24; 42 CFR 493 Chapter 8, Proficiency Test Programs for Urinalysis. These Proficiency Test Program standards are also used as for Minimal Acceptable Standards (MAS) for method validation studies and correlation studies between analyzers. Each analyte must perform within these standards to be considered minimally acceptable.

4.1. The Minimal Acceptable Standard for all analytes in method comparison is to be within ± 1 semi-quantitative category for 100% of samples with no obvious bias.

4.2. Additional Items forsurveillance:

a. Analyzer will be operational 99% of the time in a 24 hourperiod.

b. The contractor responds to all calls in accordance with section 5.6

c. Calibration: Analyzers will be calibrated and verified at intervals not to exceed a maximum of every 6 months in accordance with Federal regulatory requirements and the manufacturer's claims for acceptable performance.

Calibration will occur sooner if the analyzer exceeds internal quality control limits.

d. Measurement Range: This range must be verified for each analyzer upon installation and, as a minimum, every six months thereafter. Linearity verification will occur sooner if the analyzer exceeds internal quality control limits.

d. Quality Control material: Analyzers are monitored every 8 hours of use. This analyzer must perform within historical records established by the performance of the analyzer; performance must also be within the Federally accepted limits of performance.