PWS - DXH900.pdf

PERFORMANCE WORK STATEMENT

FOR

PREVENTIVE MAINTENANCE AND REPAIR SERVICES

OF

BECKMAN COULTER DXH 900 HEMATOLOGY ANALYZER

FOR

374TH MEDICAL GROUP

YOKOTA AIR BASE, JAPAN

374 MDSS/SGSL

PERFORMANCE WORK STATEMENT

FOR

PREVENTIVE MAINTENANCE AND REPAIR SERVICE OF

BECKMAN COULTER DxH 900 HEMATOLOGY ANALYZER

1. DESCRIPTION OF SERVICES: The Contractor shall provide scheduled preventive maintenance inspections (PMI's), calibrations, repair and on-site remedial maintenance and telephone consultation for the equipment listed in 1.2. Service shall include all travel, labor, parts, manufacturer's authorized field modifications instructions (FMI's), individual tools, and test equipment required to service and maintain the 374th Medical Group, Yokota AB leased equipment described in 1.2, in accordance with (IAW) manufacturer's specifications and FMI's.

1.2. EQUIPMENT LIST:

GENERIC NOMENCLATURE MODEL NUMBER SERIAL NUMBER ECN

Beckman Coulter DxH 900

Hematology Analyzer DxH 900 TBD TBD

1.2.1. Preventive Maintenance Inspections (PMl's): PMI's shall be scheduled as follows:

ITEM FREQUENCY PM-CAL DUE

DxH 900 Semi-annual April / October

1.3. PERFORMANCE TIME/SERVICE CALLS:

1.3.1. Routine repairs and PMI's should be accomplished during Monday through Friday between 0730 thru 1630 hours. Over the phone English speaking technical support should be available 24 hours a day seven days a week. The Contractor will perform unlimited emergency calls during normal duty hours (0700 to 1700), Monday through Friday, excluding legal holidays. If offer includes after-hours and weekend (Saturday, Sunday) emergencies and services at no additional cost to the Government (must be the same rate as normal duty hours service) as part of flat monthly rate, this must be so stated in Offer.

1.3.2. The Contractor shall provide troubleshooting assistance by telephone, Monday - Friday, 0730 thru 1630 hours, Japan Standard Time, and/or on-site support as necessary. The Contractor shall provide English speaking telephone technical support, 24 hours a day seven days per week. The Contractor shall provide all software updates, to this equipment, to include field modifications, safety corrections, revisions designed to correct software deficiencies and equipment modifications normally furnished by the manufacturer. Upgrades and modifications will be furnished at no additional cost under the contract and installed during the next PMI after the manufacturer makes them available.

1 .3.3. The time frame within which the Contractor must arrive on-site is measured from the time of verbal notification that service is required; response time for this contract will be 24 hours after service call is confirmed. Deficiency will be corrected within 1 (one) duty day when parts are available; if parts cannot be acquired within 1 duty day, the Contractor will contact the In-Garrison Maintenance Support office or Government Representative (GR) to communicate the reason for the delay.

1.3.4. The Contractor's service technician will continue uninterrupted on all services being performed until the system is 100% operational according to the manufacturer's specifications. In the event a repair is not possible, a like substitute unit will be provided until the inoperative unit is repaired, installed and accepted.

1.3.5. On-site remedial maintenance shall not include parts or service required as a result of any of the following events: Damage from accident, neglect, power surge, power failure or an operating environment not in conformance with the equipment's published specifications.

1.4. PERSONNEL:

1.4.1. The Contractor shall provide all trained personnel, labor, travel, tools, diagnostic equipment, software, hardware, firmware, materials, supplies, parts and test equipment necessary to maintain the equipment as listed in a fully functional state, IAW Original Equipment Manufacturer (OEM) specifications.

1.4.2. Minimum Personnel Qualifications: Services under this contract will be performed by individuals who have demonstrated knowledge, and competence in servicing and maintaining the specified equipment under this contract. The Contractor shall ensure repair technicians have been fully trained and experienced in testing and repairing the equipment and components on contract and are licensed/authorized to perform maintenance on the equipment. The technician should have at least 18 months experience working on the DxH 900 model analyzer or similar analyzers made by the same company.

1.5. GENERAL INFORMATION:

1.5.1. Security Requirements:

1.5.1.1. Contractor personnel or any representative of the contractor entering Yokota AB will abide by all security regulations and will be subject to security checks. The Contractor or representative will report to building 4408 In-Garrison Maintenance Support office, Room 118 to sign-in and receive a temporary access badge; the badge must be returned to In-Garrison Maintenance Support office and the representative must sign out before departing the installation.

1.6. SPECIFIC TASKS AND DELIVERABLES:

1.6.1. The Contractor, or representative, shall report to the 374th Medical Group In-Garrison Maintenance Support office building 4408 room 118, Ext. 225-3585, prior to commencing all on-site services and repairs during normal operating hours, 0730 to 1630, Monday through Friday. If services are required after normal duty hours, the staff on site will contact the Urgent Care (UC) at 225-7740. The UC will contact In-Garrison Maintenance Support office on-call technician to receive over-time authorization;

Contractor will ensure service reports, in English, are provided to the In-Garrison Maintenance Support office within twenty-four hours of the completed work.

1.6.2. The Contractor shall provide unlimited service calls during specified contract term and must provide advance notice to the In-Garrison Maintenance Support office or GR of any repairs that exceed the terms of the contract and require additional funding.

1.6.3. The Contractor shall provide all tools, parts and labor required to perform service calls. The service shall include all labor, travel, inspection, and replacement of parts to maintain the government leased equipment and associated components under this contract in a continuous working state.

1.6.4. The Contractor shall furnish and install all manufacturers' mandatory modifications and apply recalls by Food and Drug Administration (FDA) and must comply with specified lubrications, cleaning (other than operators), and parts replacement IAW OEM specifications.

1.6.5. Upon completion of each remedial maintenance visit, the Contractor shall provide the In-Garrison Maintenance Support office with a legible service report in duplicate, in English. Government Representative (GR) will countersign the report. Failure to provide a service report will result in delay of payment for service until the service report is received by the GR. Service reports shall include:

a. Type of service: i.e. routine, or emergency call.

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

c. A description of all services rendered during the visit.

d. A list of parts and their cost - total cost of service, including labor and parts.

e. Name and signature of service person(s) actually performing the repairs.

f. A list of discrepancies which may still exist for any item on the contract.

1.7. ALTERNATIVE SERVICES:

1.7.1. The Contractor shall not use subcontractors in the performance of the contract without written permission of the Contracting Officer (KO).

1.8. ACCEPTANCE:

1.8.1. Upon completion of work, an acceptance inspection will be conducted by the GR ensure all services were completed. A full service report, in English, will be submitted to the In-Garrison Maintenance Support office or GR for review. The information of service report provided by the Contractor, to include maintenance and repairs performed, and parts replaced if applicable, will be used by the customer throughout the term of the contract to perform quality assurance and cost analysis before the next option year is exercised.

1.9. FEDERAL HOLIDAYS:

374th Medical Group observes the following holidays. If a holiday falls on a Saturday, it is observed on the preceding Friday. If a holiday falls on a Sunday, it is observed on the following Monday.

Unscheduled closures may be declared by the 374th Medical Group.

New Year's Day 01 January Martin Luther King's Birthday Third Monday in January President's Day Third Monday in February Memorial Day Last Monday in May Juneteenth Third Monday in June Independence Day 04 July Labor Day First Monday in September Columbus Day Second Monday in October Veteran's Day 11 November Thanksgiving Day Forth Thursday in November Christmas Day 25 December

2. CONTRACTOR FURNISHED ITEMS:

2.1. The Contractor shall furnish all materials (excluding user consumable supplies) with OEM parts and labor and supplies necessary to perform the services and repairs; travel will be included in the overall contract cost.

2.2. The Contractor shall not remove any item of USAF-owned equipment from the medical facility for service at the contractor's establishment without the written consent of the In-Garrison Maintenance Support office or GR. Should it become necessary to remove the equipment from the facility for servicing, the Contractor shall provide, at no additional cost to the government, a loaner like item.

2.3. All replacement parts shall be provided by the Contractor. New repair parts must be used to conduct repairs on the equipment. Refurbished parts must meet OEM standards and be pre-approved by the In- Garrison Maintenance Support office or GR prior to installation. Replaced parts become the property of the United States and shall be returned to the In-Garrison Maintenance Support office. If required replacement parts are not immediately available to the Contractor while performing service calls, the Contractor shall notify the In-Garrison Maintenance Support office of the deficiency, and deliver and install all replacement parts as soon as possible. All completed work will be certified to meet OEM specifications.

2.4. Contractor shall coordinate PMls and calibrations 7 calendar days in advance with using activity.

The scheduled service shall include a complete operational check of all equipment listed, and calibration if required. Contractor shall provide the In-Garrison Maintenance Support office or GR with a product certification on the unit, annually, which compares the unit's accuracy to manufacturer specifications.

Failure to accomplish PMls or provide evidence of inspection by the first day of the month following the inspection due month, shall be resolved in accordance with FAR 52.212-4.

3. GOVERNMENT FURNISHED SERVICES:

3.1. The government shall furnish the Contractor all reasonable amounts of electric power and other utilities necessary to perform the above service.

4. HIPAA COMPLIANCE: The Contractor agrees to abide by all the requirements of the Health Insurance Portability and Accountability Act (HIPAA) as codified at 45 CFR Part 160 and Part 164, subparts A and E, and implemented by DoD 6025.18-R regarding the privacy and confidentiality of health records and information being provided and shared under the resulting contract. The Contractor shall also comply with the Business Associate Agreement under Privacy of Protected Health Information.

HIPAA is comprised of several different sections, each to be implemented by the Dept. of Health and Human Services. The medical facilities of the military services and the DOD health plans are specifically listed as covered by HIPPA. Currently, HIPAA Privacy and Security Rules, as set forth in the Code of Federal Regulations, are in effect for all MTFs. The specific implementation of HIPPA Privacy for DOD medical facility is set forth in DOD 6025.18-R, and for HIPAA Security, the requirements for AF MTF's are contained in DOD 8580.02-R and AFI 41-217, which also contains additional Information Assurance requirements for all AF MTF's. DOD 6025.18-R, DOD 8580.02-R and AFI 41-217 are incorporated herein by reference. MTRs are responsible to insure overall compliance with HIP AA requirements, which includes incorporation of certain requirements in contracts entered or amended after the respective implementation dates.

IA W these regulations the Contractor and its employees meet the definition of Business Associates.

Therefore, a Business

Associate Agreement is required by law to comply with both the HIP AA Privacy and Security regulations. This clause serves as that agreement for each MTF, whereby the Contractor and its employees agree to abide by all HIPAA Privacy and Security requirements regarding health information as defined in this clause, DOD 6025-18-R, DOD 8520.02-R and AFI 41-217. Additional HIPAA requirements will be addressed when implemented.

Introduction.

(a) Definitions. As used in this clause generally refer to the Code of Federal Regulations (CFR) definition unless a more specific provision exists in DOD 6025.18-R, DOD 8520.02-R or AFI 41-217.

Individual has the same meaning as the term "individual" in 45 CFR 164.50 1 and 164.103 and shall include a person who qualifies as a personal representative in accordance with 45 CFR 164.502(g).

Privacy Rule means the Standards for Privacy of Individually Identifiable Health Information at 45 CFR part 160 and part 164, subparts A and E.

Protected Health Information has the same meaning as the term "protected health information" in 45 CFR 164.501, limited to the information created or received by The Contractor from or on behalf of the Government.

Electronic Protected Health Information has the same meaning as the term "electronic protected health information" in 45 CFR 160.103.

Required by Law has the same meaning as the term "required by law" in 45 CFR 164.501 and 164.103.

Secretary means the Secretary of the Department of Health and Human Services or his/her designee.

Security Rule means the Health Insurance Reform: Security Standards at 45 CFR part 160,162 and part 164, subpart C.

Terms used, but not otherwise defined, in this Agreement shall have the same meaning as those terms in 45 CFR 160.103, 160.502, 164.103, 164.304 and 164.501.

(b) The Contractor agrees to not use or further disclose Protected Health Information other than as permitted or required by the Contract or as Required by Law.

(c) The Contractor agrees to use appropriate safeguards to prevent use or disclosure of the Protected Health Information other than as provided for by this Contract.

(d) The Contractor agrees to use administrative, physical, and technical safeguards that reasonably and appropriately protect the confidentiality, integrity, and availability of the electronic protected health information that it creates, receives, maintains, or transmits in the execution of this Contract.

(e) The Contractor agrees to mitigate, to the extent practicable, any harmful effect that is known to the Contractor of a use or disclosure of Protected Health Information by the Contractor in violation of the requirements of this Contract.

(f) The Contractor agrees to report to the Government any security incident involving protected health information of which it becomes aware.

(g) The Contractor agrees to report to the Government any use or disclosure of the Protected Health Information not provided for by this Contract of which the Contractor becomes aware of.

(h) The Contractor agrees to ensure that any agent, including a subcontractor, to whom it provides Protected Health Information received from, or created or received by the Contractor on behalf of the Government agrees to the same restrictions and conditions that apply through this Contract to the Contractor with respect to such information.

(i) The Contractor agrees to ensure that any agent, including a subcontractor, to whom it provides electronic Protected Health Information, agrees to implement reasonable and appropriate safeguards to protect it.

(j) The Contractor agrees to provide access, at the request of the Government, and in the time and manner designated by the Government to Protected Health Information in a Designated Record Set, to the Government or, as directed by the Government, to an Individual in order to meet the requirements under 45 CFR 164.524.

(k) The Contractor agrees to make any amendment(s) to Protected Health Information in a Designated Record Set that the Government directs or agrees to pursuant to 45 CFR 164.526 at the request of the Government or an Individual, and in the time and manner designated by the Government.

(I) The Contractor agrees to make internal practices, books, and records relating to the use and disclosure of Protected Health Information received from, or created or received by the Contractor on behalf of, the Government, available to the Government, or at the request of the Government to the Secretary, in a time and manner designated by the 'Government or the Secretary, for purposes of the Secretary determining the Government's compliance with the Privacy Rule.

(m) The Contractor agrees to document such disclosures of Protected Health Information and information related to such disclosures as would be required for the Government to respond to a request by an Individual for an accounting of disclosures of Protected Health Information in accordance with 45 CFR 164.528.

(n) The Contractor agrees to provide to the Government or an Individual, in time and manner designated by the Government, information collected in accordance with this Clause of the Contract, to permit the Government to respond to a request by an Individual for an accounting of disclosures of Protected Health Information in accordance with 45 CFR 164.528.

General Use and Disclosure Provisions

Except as otherwise limited in this Agreement, the Contractor may use or disclose Protected Health Information on behalf of, or to provide services to, the Government for treatment, payment, or healthcare operations purposes, in accordance with the specific use and disclosure provisions below, if such use or disclosure of Protected Health Information would not violate the HIP AA Privacy Rule, DOD 6025.18-R, the HIP AA Security Rule, or DOD 8580.02-R if done by the Government.

Specific Use and Disclosure Provisions

(a) Except as otherwise limited in this Agreement, the Contractor may use Protected Health Information for the proper management and administration of the Contractor or to carry out the legal responsibilities of the Contractor.

(b) Except as otherwise limited in this Agreement, the Contractor may disclose Protected Health Information for the proper management and administration of the Contractor, provided that disclosures are required by law, or the Contractor obtains reasonable assurances from the person to whom the information is disclosed that it will remain confidential and used or further disclosed only as required by law or for the purpose for which it was disclosed to the person, and the person notifies the Contractor of any instances of which it is aware in which the confidentiality of the information has been breached.

(c) Except as otherwise limited in this Agreement, the Contractor may use Protected Health Information to provide Data Aggregation services to the Government as permitted by 45 CFR 164.504(e)(2)(i)(B).

(d) Contractor may use Protected Health Information to report violations of law to appropriate Federal and State authorities, consistent with 45 CFR 164.5020)(1).

Obligations of the Government

Provisions for the Government to Inform the Contractor ofP rivacy Practices and Restrictions

(a) Upon request the Government shall provide the Contractor with the notice of privacy practices that the Government produces in accordance with 45 CFR 164.520, as well as any changes to such notice.

(b) The Government shall provide the Contractor with any changes in, or revocation of, permission by Individual to use or disclose Protected Health Information, if such changes affect the Contractor's permitted or required uses and disclosures.