W9114F22Q00800002.pdf

0011821180

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 do the follow ing:

1. Update CLINs 2019, 3019 and 4019.

2. Update the Perfromance Work Statement.

1. CONTRACT ID CODE PAGE OF PAGES

J 1 19

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

16C. DATE SIGNED

BY

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 W9114F22Q0080

X 9B. DATED (SEE ITEM 11)

09-Aug-2022

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 is extended, X 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.

U0002

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

6. ISSUED BY

3. EFFECTIVE DATE

31-Aug-2022

CODE

W40M RHCO USAHCA EUROPE

REGIONAL HEALTH CONTR OFC EUROPE

CMR 402

APO AE 09180

W9114F 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE

See Item 6

FACILITY CODECODE

EMAIL:TEL:

W9114F22Q0080

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 1449 - CONTINUATION SHEET

SUPPLIES OR SERVICES AND PRICES

CLIN 2019

The CLIN description has changed from Maintenance Services-Philips BV Pulsera to Maintenance Services - Philips EPIQ 7C.

The CLIN extended description has changed from:

Full Maintenance Non-Personal Services for the Philips BV Pulsera EQ: 53292388, ECN: 047961 in accordance with the Performance WorkStatement (PWS).Period of Performance: 26 September 2024 through 25 September

To:

Full Maintenance Non-Personal Services for the Philips EPIQ 7C Ultrasound EQ: 70573236, ECN: 086114 in accordance with the Performance WorkStatement (PWS).Period of Performance: 26 September 2024 through 25 September 2025

CLIN 3019

Services - Philips EPIQ 7C.

The CLIN extended description has changed from:

Full Maintenance Non-Personal Services for the Philips BV Pulsera EQ: 53292388, ECN: 047961 in accordance with the Performance WorkStatement (PWS).Period of Performance: 26 September 2025 through 25 September

Full Maintenance Non-Personal Services for the Philips EPIQ 7C Ultrasound EQ: 70573236, ECN: 086114 in accordance with the Performance WorkStatement (PWS).Period of Performance: 26 September 2025 through 25 September 2026

CLIN 4019

Services - Philips EPIQ 7C.

The CLIN extended description has changed from:

Full Maintenance Non-Personal Services for the Philips BV Pulsera EQ: 53292388, ECN: 047961 in accordance with the Performance WorkStatement (PWS).Period of Performance: 26 September 2026 through 25 September

Full Maintenance Non-Personal Services for the Philips EPIQ 7C Ultrasound EQ: 70573236, ECN: 086114 in accordance with the Performance WorkStatement (PWS).Period of Performance: 26 September 2026 through 25 September 2027

The following have been modified:

PERFORMANCE WORK STATEMENT

1. GENERAL INFORMATION:

1.1. NON-PERSONAL SERVICES: The Contractor shall provide all personnel, equipment, tools, materials, parts, supervision, transportation and other items and services necessary to properly maintain all equipment identified in PWS Attachment 4 – Equipment List. Services to be performed include all unscheduled routine service calls, all unscheduled/repair service visits, and all scheduled service visits as required for all Line Items. 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.

1.2. PERSONNEL:

1.2.1. The Contractor shall be able to read, write, speak and understand English.

1.2.2. The Contractor shall present a neat appearance commensurate with that required of a professional.

1.2.3. Neither uniformed personnel nor Government civilian employees shall be employed to perform services under this contract.

1.2.4. The Contractor is responsible for ensuring all country clearances, passports, visas and accreditations required by the Host Nation are obtained. Documentation requirements are subject to change as Status of Forces Agreements (SOFA) change.

1.2.5. The Contractor shall recognize that Host Nation authorities may conduct on-site inspections at any time in the Contractor’s work areas for the purpose of verifying the status of position and appropriate visas or permissions. The Contractor shall assume all costs related to submission of required documentation.

1.2.5.1. The applicable information and forms may be accessed at the internet address:

http://www.eur.army.mil/g1/content/CPD/docper.html.

1.3. ADMINISTRATIVE:

1.3.1. SECURITY.

1.3.1.1. U.S. CITIZEN(s).

1.3.1.1.2. Immediately upon award of the contract the COR will begin the process that affords the Contractor access to the installation.

1.3.1.2. NON-U.S. CITIZEN(s).

1.3.1.2.1. Immediately after award of the contract, the Contractor shall submit to the COR a request for a U.S.

Installation Gate Pass. On successful completion of necessary U.S. Government personnel security clearance requirements, an Installation Pass will be issued by the Installation Coordinator (see PWS Attachment 2 – Installation Pass). The U.S. Government will conduct and assume the cost of background investigations for required clearances. The Installation Pass shall be returned to the COR immediately upon termination or expiration of the contract.

1.3.2. TRAINING.

1.3.2.1. Contractor personnel are not expected to require training for this contract requirement.

1.3.3. PHYSICAL SECURITY.

1.3.3.1. The Contractor shall safeguard all Government property provided for the Contractor’s use. At the close of each work period, Government facilities, equipment and materials shall be secured.

1.3.3.1. KEY CONTROL/BADGE CONTROL.

1.3.3.1.1. The Contractor shall ensure all keys/badges issued to the Contractor are not lost or misplaced and are not used by unauthorized persons. The Contractor shall assure keys/badges issued by the Government are not duplicated.

1.3.3.1.1.1. The Contractor shall report lost or duplicated keys/badges to the COR within 24 hours.

1.3.3.1.2. 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 duplicated or lost, all locks and keys for that system will be replaced by the Government and the total cost deducted from payment due the Contractor.

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

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

1.3.4. CONSERVATION OF UTILITIES.

1.3.4.1. The Contractor shall observe energy conservation policies, to include:

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

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

1.3.5. Vehicle Operation, Registration and Insurance.

1.3.5.1. The Contractor shall comply with the local installation requirements for vehicle registration. Any vehicle operated in performance of this contract must have appropriate liability coverage.

1.4. HOURS OF PERFORMANCE:

1.4.1. ROUTINE/UNSCHEDULED SERVICE:

1.4.1.1. The Contractor shall provide unlimited routine/unscheduled service during normal workdays; Monday through Friday, between the hours of 0800-1700 excluding local national holidays. Unscheduled repair service calls shall be accepted only from the COR, Clinical Engineering Branch or their designated representative in the COR’s absence. (Point-of-Contact List Attachment 1)

1.4.1.2. The Contractor’s qualified service technician shall be on site to provide routine services or service requiring immediate repair. Scheduled services for preventive maintenance, safety and calibration shall be performed as required by the manufacturer’s specifications and this statement of work. The equipment shall be repaired and operational within 48 hours after initial response by the Contractor. Scheduled services shall be completed no later than the 20th day of the assigned month.

1.4.1.3. The Contractor’s qualified service technician shall provide repair service based on urgency of device and customer inquiry per the timetable below:

Priority 1 – Patient at risk - There is a risk to patients, working is not permitted initial response time from Philips dispatch 2 hours (call back or e-mail), Remote Center Engineer 4 hours for pre-qualification (call back or e-mail). Engineer on-site the next working day.

Priority 2 – System down - Severe system disturbance, and system inoperable for its intended use initial response time from Philips dispatch 2 hours (call back or e-mail), Remote Center Engineer 4 hours for pre-qualification (call back or e-mail). Engineer on-site the next working day.

Priority 3 – System restricted - Failure of key functionalities, limited working is possible initial response time from Philips dispatch 2 hours (call back or e-mail), Remote Center Engineer 4 hours for pre-qualification (call back or e-mail). Appointments for an Engineer on-site are made by phone or email in coordination with the customer.

Priority 4 – Intermittent Problem Temporary malfunction, working is possible with minor restrictions initial response time from Philips dispatch 2 hours (call back or e-mail), Remote Center Engineer 4 hours for pre-qualification (call back or e-mail). Appointments for Engineer on-site are made by phone or email in coordination with the customer.

Priority 5 – Scheduled Activity - Inquiry or plannable activity; system is ready for operation Appointments for Engineer on-site are made by phone or email in coordination with the customer

1.4.1.4. 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 Clinical Engineering Branch in writing as to the reason(s) (i.e. parts non-availability, etc.) to ensure the medical treatment facility can plan accordingly for patient schedules and emergency medical care.

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

1.5. CONDUCT:

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

1.5.2. SEXUAL ASSAULT PREVENTION AND RESPONSE PROGRAM (SHARP).

1.5.2.1. The Contractor shall comply with 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.

1.5.2.2. 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.

1.5.2.3. 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.

1.5.3. IMPAIRED CONTRACTOR PERSONNEL.

1.5.3.1. At any time during the performance of this contract, the Contracting Officer, Contracting Officer’s Representative (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 the Contractor.

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.

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

AR - Army Regulation CLIN - Contract Line Item Number CONUS - Continental United States COR - Contracting Officer's Representative DA - Department of the Army DoD - Department of Defense DODI - Department of Defense Instruction FAR - Federal Acquisition Regulation JC - Joint Commission KO - Contracting Officer MEDDAC - Medical Department Activity MTF - Medical Treatment Facility OCONUS - Outside the Continental United States Pam - Pamphlet PAR - Performance Assessment Report PBWS - Performance Based Work Statement PPIMS - Past Performance Information Management System QA - Quality Assurance QA&I - Quality Assessment & Improvement QC - Quality Control

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. The Contractor shall maintain Government furnished supplies, equipment and work areas in a safe, orderly and clean condition.

3.1.1. FACILITIES. No facilities will be provided.

3.1.2. EQUIPMENT. No equipment will be provided

3.1.3. MATERIALS. No materials will be provided.

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

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

3.1.5. GOVERNMENT UNIQUE TRAINING. Contractor personnel are not expected to require training for this contract requirement.

4. CONTRACTOR FURNISHED SUPPLIES/SERVICES:

4.1. The Contractor shall furnish all supplies/services required in the performance of this contract except those listed in paragraph 3 above.

5. SPECIFIC TASKS:

5.1. Non-personnel 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. (PWS Attachments 4).

5.2. 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.

5.2.1. The Contractor shall maintain the equipment listed in proper operating condition as described in the manufacturers’ literature. The Contractor shall provide:

5.2.2. Coordinated scheduled calibration and preventive maintenance inspection shall be performed as specified for each unit or system in the equipment list (PWS Attachment 4). These services shall be performed during the months indicated and all unscheduled routine and all unscheduled/repair services as required. The scheduled calibration and preventive maintenance shall include written documentation of servicing, lubrication, cleaning, adjustments, operational tests and calibration/verification in accordance with manufacturers’ specifications and all applicable Government, both foreign and domestic, and Army regulations. Calibration documentation shall include a list of all test, measurement and diagnostic equipment. This list shall include nomenclature, model, serial number, date it was calibrated and the date its calibration is due.

5.2.3. Preventive maintenance shall include cleaning, replacement of missing or defective parts, modules, covers, lamps and keys, a complete inspection, 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 that would affect safety, etc.) and 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.

5.2.3.1. Contractor’s service representative shall be factory trained and have a minimum of 2 years of experience working on the contracted equipment.

5.2.3.2. Contractor must furnish all software updates issued by the equipment manufacturer. Software updates are defined as software or hardware versions that improve functions or that solve or correct problems in previous versions. Software updates are not upgrades, which introduce new characteristics or expanded functionality and therefore go beyond the scope of a repair or maintenance.

5.2.3.3. Contractor shall have access to all necessary diagnostic software (if applicable).

5.2.3.4. The Contractor shall complete DD Form 2164 (X-Ray Verification/Certification Worksheet) in accordance with instructions provided in TB 38-750-2 if the equipment requires such documentation. A continuation sheet shall be attached to the DD Form 2164 indicating the manufacturer, model, serial number and date of the calibration expiration of all items of test, measurement and diagnostic equipment used to perform the calibration.

5.2.3.5. Required forms and extracts from pertinent directives shall be furnished to the Contractor’s service representative by the Government.

5.2.3.6. If the Contractor’s calibration equipment produces a printed summary of the calibration procedure used, attach the printed summary to the DD Form 2164. Ensure the heading of the DD Form 2164 is filled out and the form is properly signed.

5.2.3.7. The frequency of preventive maintenance and safety inspections shall be done in accordance with the manufacturer’s guidelines with a minimum of one scheduled service per year.

5.2.4. All preventive maintenance inspections/verifications/calibrations shall be performed in accordance with the manufacturer’s service literature, which shall be located with the equipment or provided by the Contractor.

5.2.5. In accordance with MEDCOM directives: Upon completion of calibration, the Contractor shall affix or update a DD Form 2163 to the equipment in accordance with instructions provided in TB 38-750-2. Required DD Forms and extracts from pertinent directives will be furnished to the Contractor by the Clinical Engineering Branch.

5.2.6. The Contractor shall only accept calls for service/repairs from the COR, Equipment Management Branch.

5.2.7. Prior to and upon completion of “any” scheduled or unscheduled service, the Contractor service representative must report to the Contracting Officer’s Representative (COR), Equipment Management Branch at:

Landstuhl Regional Medical Center Equipment Management Branch Building 3760 Ward 4B 66849 Landstuhl Tel. 06371-9464-5217 Fax: 06371-86-7258

5.2.8. On the day services (scheduled and/or unscheduled) are completed, the Contractor’s service technician shall prepare and initial a legible, preferably typed service report in English and present it to the COR, Equipment Management Branch or his/her designated representative for signature. This report shall include the following information:

(1) Services performed (i.e., preventive maintenance, repair, calibration, etc.)

(2) What systems or components failed by serial number (reason for call)

(3) Start date/time

(4) Completion date/time

(5) Name of service technician

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

(7) Travel time

(8) Repair time

(9) Travel, repair and parts cost

(10) Location of services performed

5.2.9. In the event all 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. Within 10 days after completion of service the Contractor shall provide/fax a legible, preferably typed, copy of the remainder of the required information in English to:

Landstuhl Regional Medical Center Equipment Management Branch Building 3760 Ward 4B 66849 Landstuhl Tel. 06371-9464-5217 Fax: 06371-86-7258

5.2.10. The Contractor “must” obtain authorization from the COR, Equipment Management Branch 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 COR, Equipment Management Branch 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. THE USE OF CELLULAR PHONES AND 2-WAY RADIOS:

5.3.1. The use of cellular phones and 2-way radios is expressly forbidden in certain areas of Medical Treatment Facilities and Health Clinics. The Contractor shall not use cellular phones or radios in these areas.

5.4. RECEIPT OF SERVICES:

5.4.1. Receipt of services will be acknowledged after receipt of all completed service reports for any scheduled calibration, preventive maintenance or unscheduled routine, and repair service 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 COR, Equipment Management Branch.

POC for admin questions:

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

Landstuhl Regional Medical Center Equipment Management Branch Building 3760 Ward 4B 66849 Landstuhl Tel. 06371-9464-5217 Fax: 06371-86-7258

5.5. JOB SITE LOCATION.

5.5.1. For exact equipment location see equipment list (PWS Attachment 4).

5.6. WORK CONDITIONS.

5.6.1. Preventive maintenance inspection and calibration must be performed per manufacturers guidelines for scheduled maintenance with a minimum of one scheduled service per year.

5.6.2. The Contractor shall notify the COR, Clinical Engineering Branch, or their designated representative in the COR’s absence, of the exact date and time within ten (10) days prior to scheduled preventive maintenance services.

5.6.3. All unscheduled repairs shall be verified by a MER (Medical Equipment Repairer) prior to notification of the Contractor by the COR, Clinical Engineering Branch.

5.6.4. The Contractor shall respond to unscheduled repair service calls from the POC within one (1) working day, Monday through Friday between the hours of 0800 and 1700 excluding local national holidays. Unscheduled repair service calls shall be accepted only from the COR, Clinical Engineering Branch.

5.6.4.1. COMPLETION OF UNSCHEDULED REPAIRS.

5.6.4.1.2 The Contractor’s qualified service technician shall provide repair service based on urgency of device and customer inquiry per the timetable covered under 1.4.1.3.

5.6.5. REPLACEMENT PARTS:

5.6.5.1. 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 standards set forth in 21 CFR 1020.30 (applicable to radiation producing equipment only), for installation in medical equipment. This regulation can be reviewed in full context at the Equipment Management Branch.

5.6.5.2. In place of new parts, factory refurbished exchange parts per the manufacturer’s spare parts procedures and policies may be used. The Contractor’s representative shall inform the POC and request approval prior to the use of a refurbished part.

5.6.5.3. 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.

5.7. Smoking is prohibited within Landstuhl Regional Medical Center (LRMC) and its clinics and within 15 meters of any LRMC building.

5.8. Prior to performing work, a Contractor's representative shall report to and get from the Equipment Management Branch, (LRMC, Ward 4B) a Visitor’s Badge. The badge must be returned to the Equipment Management Branch prior to departing LRMC.

5.8.1. Repairs that cannot be performed at the Government site may be performed at the Contractor’s site provided the POC 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.

5.8.2. Repair of equipment for damages resulting from improper handling by the user is not covered by this contract unless modified to include such repair. If the Contractor finds damage is due to improper handling, the Contractor’s representative shall within one (1) working day report the extent of the damage and submit a cost estimate for repair to the COR, Equipment Management Branch. The repair shall not be performed without a written modification to this contract or a one-time purchase order authorizing such repair. The COR, Equipment Management Branch will review the estimate and submit a separate repair request, processed to include the funding to the Administering Contracting Officer, so the contract can be modified or another purchase order issued to authorize such repair.

5.9. The Contractor shall complete DD Form 2164 in accordance with the instructions provided in TB 38-750-2. A continuation sheet shall be attached to the DD Form 2164 indicating manufacturer, model number, serial number and date of calibration expiration for all test, measurement and diagnostic equipment items used to perform calibration. Required forms and extracts from pertinent directives will be furnished to the Contractor by the Government.

5.9.1. Within one (1) working day after completion of a repair, the Contractor’s representative shall furnish the POC one (1) copy of an initialed and legibly written or typed service report for all services performed to the COR, Equipment Management Branch or his/her designated representative for signature. The service report shall be in English, clearly legible and shall contain, as a minimum, the following information:

- Nomenclature and serial number of item(s) involved.

- Date completed.

- Description of services performed (i.e., preventive maintenance, repair, calibration, etc.)

- 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(s) performing services.

5.9.2. In the event that pricing data is not available to the Contractor’s representative, he/she shall provide the information required in Para. 5.9.1 above without the labor/travel rate and parts cost. The Contractor’s representative shall, however submit the pricing data no later than ten (10) working days after completion of services to:

COR, Equipment Management Branch Amerikanisches Krankenhaus Gebaeude 3760, Ward 4B 66849 Landstuhl

5.9.3. All correspondence, service reports and invoicing shall be in English and clearly legible.

5.9.4. All Contractors’ representatives shall be sufficiently fluent in the English language to effectively communicate with the COR.

5.10. The COR will maintain surveillance checklists covering areas in paragraphs 5.4.1. in Performance Standards above. All work is subject to inspection and acceptance by the Government. Monitoring method is 100% inspection by COR or Government representative in-charge at the locations of equipment for performance requirements summary (PRS) items in Para 5.4.1. See PWS Attachment 3 - Performance Requirements Summary (Performance Objective, Performance Standard, AQL, Monitoring Method, and Incentive/De-incentive) the COR will use to evaluate the Contractor’s performance.

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

6.1. The following is a list of basic publications applicable to this contract. Current issues of many DA publications can be accessed at http://www.apd.army.mil. Publications and forms not on the internet can be obtained from the

MTF.

6.1.1. The Publications have been coded as mandatory or advisory. The Contractor is obligated to follow those coded as mandatory only to the extent 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. PUBLICATIONS:

6.2.1. ADVISORY

6.2.1.1. Army Regulation 600-20, Army Command Policy, 6 November 2014

6.2.1.2. OTSG/MEDCOM Policy Memo 16-033, Policy for Reporting Incidents of Sexual Assault and Sexual Harassment under the Sexual Assault Prevention and Responses Program (SHARP), 29 March 2016.

6.2.2. MANDATORY:

6.2.2.1. 21 CFR 1020.30.

6.2.2.2. NFPA 99, Chapter 7.

6.3. The following is a listing of forms that are required.

6.3.1. Department of Defense Forms

DD 2163 - Medical Equipment Verification/Certification DD 2164 - X-Ray Verification Certification Worksheet

7. Exclusion from Participation in Federal Health Care Programs (October 2015)

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

7.2. Prior to start of contract performance, the Contractor shall

(a) query the Lists to determine whether the name of any person the Contractor employs or contracts with to provide services or items for which payment may be made under this contract appears on the Lists, and

(b) certify to the Contracting Officer that the Contractor has queried the Lists and no such names appear on either of the Lists.

7.3. During performance of the contract, and prior to persons other than those whose names were queried in accordance with paragraph 2, above, (hereinafter “new persons”) providing services or items under the contract, the Contractor shall

(a) query the Lists as in paragraph 2, and

(b) certify to the Contracting Officer that the names of such new persons do not appear on either of the Lists.

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

7.5. Should any person providing items or services under the contract appear on either of the Lists at any time during contract performance, the Contractor shall

(a) in cases where the Contractor identified the person, notify the Contracting Officer, and

(b) promptly remove that person from the contract.

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

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

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

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

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

8. TOBACCO FREE MEDICAL CAMPUS (TFMC).

In accordance with Army Regulation 600-63, paragraph 7-3, 14 April 2015; Operations Order 15-48 (Army Medical Command (MEDCOM) Tobacco Free Living – USAMEDCOM), 8 May 2015; and any Operations Order, regulation or other instruction implementing, defining or otherwise addressing the Tobacco Free Medical Campus (TFMC) on any military installation or DoD-controlled location, Contractor personnel are prohibited from using any tobacco product on or within any TFMC while performing under this contract. TFMCs are established at each installation or DoD-controlled location and include:

(1) any property or non-residential building that is operated, maintained or assigned to support medical activities, including but not limited to, hospitals, medical laboratories, outpatient clinics (including medical, dental, and veterinary facilities), or aid stations operating for the primary purpose of delivering medical care and services for DOD eligible beneficiaries and /or meeting the mission of the Army Medical Command;

(2) all other facilities in which medical activities or administration take place, to include HQ MEDCOM and Defense Health Headquarters;

(3) all internal roadways, sidewalks and parking lots; and

(4) all sidewalks, parking lots and grounds external but adjacent to the building or related to the migratory corridors surrounding the medical facility. The Contractor shall obtain from the COR any orders, regulations, instructions or other documents implementing, defining or otherwise addressing the TFMC for any given installation or DoD-controlled location where Contractor personnel may perform under this contract and shall instruct Contractor personnel on the TFMC limitations for installations or DoD-controlled locations where they may perform under this contract.

9. Non-Defense Health Agency (Non-DHA) Health Insurance Portability and Accountability Act (HIPAA) Business Associate Agreement (BAA) (7 July 2014)

Introduction

In accordance with 45 CFR 164.502(e)(2) and 164.504(e) and paragraph C.3.4.1.3 of DoD 6025.18-R, “DoD Health Information Privacy Regulation,” January 24, 2003, this document serves as a BAA between the signatory parties for purposes of the HIPAA and the “HITECH Act” amendments thereof, as implemented by the HIPAA Rules and DoD HIPAA Issuances (both defined below). The parties are a DoD Military Health System (MHS) component, acting as a HIPAA covered entity, and a DoD contractor, acting as a HIPAA business associate. The HIPAA Rules require BAAs between covered entities and business associates. Implementing this BAA requirement, the applicable DoD HIPAA Issuance (DoD 6025.18-R, paragraph C3.4.1.3) provides that requirements applicable to business associates must be incorporated (or incorporated by reference) into the contract or agreement between the parties.

(a) Catchall Definition. Except as provided otherwise in this BAA, the following terms used in this BAA shall have the same meaning as those terms in the DoD HIPAA Rules: Data Aggregation, Designated Record Set, Disclosure, Health Care Operations, Individual, Minimum Necessary, Notice of Privacy Practices (NoPP), Protected Health Information (PHI), Required By Law, Secretary, Security Incident, Subcontractor, Unsecured Protected Health Information, and Use.

—Breach means actual or possible loss of control, unauthorized disclosure of or unauthorized access to PHI or other PII (which may include, but is not limited to PHI), where persons other than authorized users gain access or potential access to such information for any purpose other than authorized purposes, where one or more individuals will be adversely affected. The foregoing definition is based on the definition of breach in DoD Privacy Act Issuances as defined herein.

—Business Associate shall generally have the same meaning as the term “business associate” in the DoD HIPAA Issuances, and in reference to this BAA, shall mean Philips GmbH.

—Agreement means this BAA together with the documents and/or other arrangements under which the Business Associate signatory performs services involving access to PHI on behalf of the MHS component signatory to this

BAA.

—Covered Entity shall generally have the same meaning as the term “covered entity” in the DoD HIPAA Issuances, and in reference to this BAA, shall mean U.S. Army MEDCOM.

—DHA Privacy Office means the DHA Privacy and Civil Liberties Office. The DHA Privacy Office Director is the HIPAA Privacy and Security Officer for DHA, including the National Capital Region Medical Directorate

(NCRMD).

—DoD HIPAA Issuances means the DoD issuances implementing the HIPAA Rules in the DoD Military Health System (MHS). These issuances are DoD 6025.18-R (2003), DoDI 6025.18 (2009), and DoD 8580.02-R (2007).

—DoD Privacy Act Issuances means the DoD issuances implementing the Privacy Act, which are DoDD 5400.11 (2007) and DoD 5400.11-R (2007).

—HHS Breach means a breach that satisfies the HIPAA Breach Rule definition of breach in 45 CFR 164.402.

—HIPAA Rules means, collectively, the HIPAA Privacy, Security, Breach and Enforcement Rules, issued by the U.S. Department of Health and Human Services (HHS) and codified at 45 CFR Part 160 and Part 164, Subpart E (Privacy), Subpart C (Security), Subpart D (Breach) and Part 160, Subparts C-D (Enforcement), as amended by the 2013 modifications to those Rules, implementing the “HITECH Act” provisions of Pub. L. 111-5. See 78 FR 5566- 5702 (Jan. 25, 2013) (with corrections at 78 FR 32464 (June 7, 2013)). Additional HIPAA rules regarding electronic transactions and code sets (45 CFR Part 162) are not addressed in this BAA and are not included in the term HIPAA Rules.

—Service-Level Privacy Office means one or more offices within the military services (Army, Navy, or Air Force) with oversight authority over Privacy Act and HIPAA privacy compliance.

I. Obligations and Activities of Business Associate

(a) The Business Associate shall not use or disclose PHI other than as permitted or required by the Agreement or as required by law.

(b) The Business Associate shall use appropriate safeguards, and comply with the DoD HIPAA Rules with respect to electronic PHI, to prevent use or disclosure of PHI other than as provided for by the Agreement.

(c) The Business Associate shall report to Covered Entity any Breach of which it becomes aware, and shall proceed with breach response steps as required by Part V of this BAA. With respect to electronic PHI, the Business Associate shall also respond to any security incident of which it becomes aware in accordance with any Information Assurance provisions of the Agreement. If at any point the Business Associate becomes aware that a security incident involves a Breach, the Business Associate shall immediately initiate breach response as required by part V of this BAA.

(d) In accordance with 45 CFR 164.502(e)(1)(ii)) and 164.308(b)(2), respectively), as applicable, the Business Associate shall ensure that any subcontractors that create, receive, maintain, or transmit PHI on behalf of the Business Associate agree to the same restrictions, conditions, and requirements that apply to the Business Associate with respect to such PHI.

(e) The Business Associate shall make available PHI in a Designated Record Set, to the Covered Entity or, as directed by the Covered Entity, to an Individual, as necessary to satisfy the Covered Entity obligations under 45

CFR 164.524.

(f) The Business Associate shall make any amendment(s) to PHI in a Designated Record Set as directed or agreed to by the Covered Entity pursuant to 45 CFR 164.526, or take other measures as necessary to satisfy Covered Entity’s obligations under 45 CFR 164.526.

(g) The Business Associate shall maintain and make available the information required to provide an accounting of disclosures to the Covered Entity or an individual as necessary to satisfy the Covered Entity’s obligations under 45

CFR 164.528.

(h) To the extent the Business Associate is to carry out one or more of Covered Entity's obligation(s) under the HIPAA Privacy Rule, the Business Associate shall comply with the requirements of HIPAA Privacy Rule that apply to the Covered Entity in the performance of such obligation(s); and

(i) The Business Associate shall make its internal practices, books, and records available to the Secretary for purposes of determining compliance with the HIPAA Rules.

II. Permitted Uses and Disclosures by Business Associate

(a) The Business Associate may only use or disclose PHI as necessary to perform the services set forth in the Agreement or as required by law. The Business Associate is not permitted to de-identify PHI under DoD HIPAA issuances or the corresponding 45 CFR 164.514(a)-(c), nor is it permitted to use or disclose de-identified PHI, except as provided by the Agreement or directed by the Covered Entity.

(b) The Business Associate agrees to use, disclose and request PHI only in accordance with the HIPAA Privacy Rule “minimum necessary” standard and corresponding DHA policies and procedures as stated in the DoD HIPAA Issuances.

(c) The Business Associate shall not use or disclose PHI in a manner that would violate the DoD HIPAA Issuances or HIPAA Privacy Rules if done by the Covered Entity, except uses and disclosures for the Business Associate’s own management and administration and legal responsibilities or for data aggregation services as set forth in the following three paragraphs.

(d) Except as otherwise limited in the Agreement, the Business Associate may use PHI for the proper management and administration of the Business Associate or to carry out the legal responsibilities of the Business Associate. The foregoing authority to use PHI does not apply to disclosure of PHI, which is covered in the next paragraph.

(e) Except as otherwise limited in the Agreement, the Business Associate may disclose PHI for the proper management and administration of the Business Associate or to carry out the legal responsibilities of the Business Associate, provided that disclosures are required by law, or the Business Associate obtains reasonable assurances from the person to whom the PHI is disclosed that it will remain confidential and used or further disclosed only as required by law or for the purposes for which it was disclosed to the person, and the person notifies the Business Associate of any instances of which it is aware in which the confidentiality of the information has been breached.

(f) Except as otherwise limited in the Agreement, the Business Associate may use PHI to provide Data Aggregation services relating to the Covered Entity’s health care operations.

III. Provisions for Covered Entity to Inform Business Associate of Privacy Practices and Restrictions

(a) The Covered Entity shall provide the Business Associate with the notice of privacy practices that the Covered Entity produces in accordance with 45 CFR 164.520 and the corresponding provision of the DoD HIPAA Issuances.

(b) The Covered Entity shall notify the Business Associate of any changes in, or revocation of, the permission by an Individual to use or disclose his or her PHI, to the extent that such changes affect the Business Associate’s use or disclosure of PHI.

(c) The Covered Entity shall notify the Business Associate of any restriction on the use or disclosure of PHI that the Covered Entity has agreed to or is required to abide by under 45 CFR 164.522, to the extent that such changes may affect the Business Associate’s use or disclosure of PHI.

IV. Permissible Requests by Covered Entity

The Covered Entity shall not request the Business Associate to use or disclose PHI in any manner that would not be permissible under the HIPAA Privacy Rule or any applicable Government regulations (including without limitation, DoD HIPAA Issuances) if done by the Covered Entity, except for providing Data Aggregation services to the Covered Entity and for management and administrative activities of the Business Associate as otherwise permitted by this BAA.

V. Breach Response

(a) In general.

In the event of a breach of PII/PHI held by the Business Associate, the Business Associate shall follow the breach response requirements set forth in this Part V, which is designed to satisfy both the Privacy Act and HIPAA as applicable. If a breach involves PII without PHI, then the Business Associate shall comply with DoD Privacy Act Issuance breach response requirements only; if a breach involves PHI (a subset of PII), then the Business Associate shall comply with both Privacy Act and HIPAA breach response requirements. A breach involving PHI may or may not constitute an HHS Breach. If a breach is not an HHS Breach, then the Business Associate has no HIPAA breach response obligations. In such cases, the Business Associate must still comply with breach response requirements under the DoD Privacy Act Issuances.

If the DHA Privacy Office determines that a breach is an HHS Breach, then the Business Associate shall comply with both the HIPAA Breach Rule and DoD Privacy Act Issuances, as directed by the DHA Privacy Office, regardless of whether the breach occurs at DHA or at one of the Service components. If the DHA Privacy Office determines that the breach does not constitute an HHS Breach, then the Business Associate shall comply with DoD Privacy Act Issuances, as directed by the applicable Service-Level Privacy Office. The Business Associate shall contact the Covered Entity for guidance when the incident is not an HHS Breach.

This Part V is designed to satisfy the DoD Privacy Act Issuances and the HIPAA Breach Rule as implemented by the DoD HIPAA Issuances. In general, for breach response, the Business Associate shall report the breach to the Covered Entity, assess the breach incident, notify affected individuals, and take mitigation actions as applicable.

Because DoD defines “breach” to include possible (suspected) as well as actual (confirmed) breaches, the Business Associate shall implement these breach response requirements…