2c Atch 3 PWS Misawa.pdf

Attachment 4 for FA520921Q0016

PERFORMANCE-BASED WORK STATEMENT

FOR

REFERENCE LABORATORY SERVICES

35 MDSS AT MISAWA AIR BASE, JAPAN

35 MDSS/SGSL

26 Oct 2020

PERFORMANCE-BASED WORK STATEMENT

REFERENCE LABORATORY SERVICES FOR 35 MDSS AT MISAWA AB, JAPAN

1. DESCRIPTION OF SERVICES/GENERAL INFORMATION: The Contractor shall provide all personnel, equipment, tools, materials, supervision, and other items and services necessary to perform reference laboratory services for 35 MDSS at Misawa Air Base Japan in accordance with the terms and conditions specified in Performance-based Work Statement (PWS), subject contract, Japanese Laws and commercial practices in the commercial market.

1.1. REFERENCE LABORATORY TESTING SERVICES:

1.1.1. The Contractor shall provide reference laboratory testing services to 35 MDSS Clinical Laboratory at Misawa Air Base Hospital.

1.1.2. Service shall include courier pick-up/transportation of all specimens from the 35 MDSS Clinical Laboratory to the Contractor.

1.1.3. The Contractor shall provide reference laboratory testing for any procedures that cannot be performed by the 35 MDSS Clinical Laboratory or any other military reference laboratory testing facility. A current price schedule and test catalog will be provided to the laboratory at the beginning of each calendar year.

1.1.4. The Contractor shall report all laboratory results in English or with English translation neatly written on the original report. Normal or expected reference ranges should be included in the result report. Laboratory results must be translated to English by trained laboratory personnel who are aware of testing methods, normal and abnormal reference ranges to ensure results of significance are reported and handled appropriately. In no circumstances will the results be left up to the 35 MDSS laboratory staff to translate or for untrained personnel to translate due to the risk of misinterpretation.

1.1.5. Specimen collection containers shall be provided by the Contractor in the event that the 35 MDSS Laboratory containers are deemed unfit for testing by the contractor. Specimen containers provided by the Contractor should have the expiration date clearly marked on the container or on a bag holding the containers. The 35 MDSS Laboratory staff will track expiration dates of any containers provided by the Contractor and request replacements as needed.

1.1.6. The Contractor shall maintain local HIPAA standards. The Contractor shall not disclose any information regarding laboratory testing to any agency or office other than the 35 MDSS Clinical Laboratory.

1.1.7. The Contractor shall maintain a current accreditation with the College of American Pathologists (CAP) and provide the 35 MDSS Clinical Laboratory with a current copy of the inspection certificate.

The contractor will ensure that all testing which is reported to the 35 MDSS Clinical Laboratory has been performed by a CAP accredited laboratory.

1.2. TECHNICAL DATA: The Contactor shall maintain and make available Test Reference Guide, Price List and Lab Request Forms, in English, for the testing being offered. All special specimen handling or unique processing requirements shall be made available in the test reference guide. The Contractor shall also be responsible to provide in writing changes to test reference ranges. All reference range changes must be provided to the 35 MDSS Clinical Laboratory Service before or at time of implementation by the Contractor.

1.3. GENERAL INFORMATION:

1.3.1. QUALITY ASSURANCE: The Government will evaluate the Contractor’s performance to ensure results are being provided in a timely manner and that all requested testing is being completed.

Laboratory accessions, reported results and a monthly bill for services performed will be reconciled to ensure all required testing has been completed.

1.3.2. DESIGNATED REPRESENTATIVES: The names of the GR and personnel authorized to place calls shall be provided to the Contractor at the time of contract award.

1.3.3. GOVERNMENT REMEDIES: The Contracting Officer shall follow the requirements of FAR 52.212-4, Contract Terms and Conditions for Commercial Items, for the Contractor’s failure to perform satisfactory services or failure to correct nonconforming services.

1.3.4. HOURS OF OPERATION:

1.3.4.1. The Contractor shall perform the required services for Reference Laboratory Services for 35 MDSS at Misawa Air Base between the hours of 0730 hours to 1630 hrs, Monday through Friday.

1.3.4.2. RECOGNIZED HOLIDAYS: The Contractor is required to provide the service on the following Federal Holidays or MTF “Down Days”.

U.S. Holidays

1st January New Year’s Day 3rd Monday of January Martin Luther King, Jr.’s Birthday 3rd Monday of February Washington’s Birthday Last Monday of May Memorial Day 4th of July Independence Day 1st Monday of September Labor day 2nd Monday of October Columbus Day 11th of November Veterans Day 4th Thursday of November Thanksgiving Day 25th of December Christmas Day

Note: Normally, holidays that fall on Saturday will be observed the preceding Friday.

Holidays falling on a Sunday will be observed the following Monday.

1.4. SPECIAL QUALIFICATIONS FOR CONTRACTOR PERSONNEL:

1.4.1. CONTRACT MANAGER: The Contractor shall provide a Contract Manager (CM) who shall be responsible for the performance of the work. The name of this person, and an Alternate Contract

Manager (ACM), who shall act for the Contractor when the manager is absent, shall be designated in writing to the Contracting Officer. The Contractor shall provide telephone numbers and cell phones numbers where the Contract Manager and Alternate(s) can be contacted for placing a call for services.

The Contract Manager or Alternate shall have full authority to act for the Contractor on all contract matters.

1.4.2. The Contract Manager and Alternate(s) must be able to read, write, speak and understand English or provide a translator.

1.4.3. ADMINISTRATIVE CONTROL: The Contractor’s personnel for courier service shall report to the following address:

35 MDSS

Clinical Laboratory Room LC20, Bldg. 99 Misawa Air Base, Japan

1.4.4. CONTRACTOR EMPLOYEES: The Contractor shall not employ any 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 installation and its population.

1.4.5. All Contractor personnel shall present a neat appearance and be easily recognized as Contractor employees by having the appropriate credentials/identification, contact information for the contractor and reference material for the services being contracted for. If the contractor uses a subcontractor to provide transportation services they will ensure the subcontractor adheres to the aforementioned criteria.

1.5. SECURITY REQUIREMENT: The Contractor shall obtain the following pass and identification items:

1.5.1. BASE PASSES: The Contractor personnel will be issued base passes (identification cards) which shall be carried by the individual bearers at all times while on United States Government premises. The Contractor shall submit written requests for issuance of base passes to the Contracting Officer. The Contractor shall be responsible for all base passes issued to their personnel by the Japanese Pass Section at Misawa Air Base. Upon termination or completion of the contract, the Contractor shall turn in all issued passes to the Japanese Pass Section at Misawa Air Base.

1.5.2. VEHICLE PASSES: The Contractor vehicles used in the performance of work under this contract shall be registered and maintained in accordance with applicable paragraphs of MISAWAABI31-116, Misawa Air Base Motor Vehicle Traffic Supervision. All Contractor personnel operating a motor vehicle on this installation shall be aware of and abide by current driving policies.

All Contractor personnel occupying a vehicle, while the vehicle is inside the confines of this installation, shall wear seat belts. There will be no exceptions to this policy. Any contractor traffic violations may result in the denial of further installation driving.

1.5.3. All Contractor employees shall be instructed on accident prevention and safety. Special emphasis shall be placed on safe and proper working conditions. The Contractor shall conduct training for all employees on appropriate safety measures and on the employee’s obligation to obey all existing safety regulations.

1.5.4. GATE CONTROL: Unscheduled gate closures by the Security Police may occur at any time and personnel entering or exiting the installation may experience a delay. Privately owned vehicles of contractor’s personnel are subject to being searched pursuant to applicable regulations.

Contractor’s personnel shall comply with Misawa Air Base rules, regulations and directives while on the installation. The award of this contract does not create a right to have access to any military installation. Any violation of an installation regulation or Japanese law may result in the termination of the privilege to enter one or more military installations

1.6. Unacceptable performance work must be resolved/rescheduled with the GR and completed within five (5) calendar days. It is the responsibility of the Contractor to reschedule the work with the GR.

Any items not completed by the Contractor at the scheduled time shall be considered unacceptable.

1.7. PERFORMANCE OF SERVICES DURING CRISIS DECLARED BY THE NATIONAL

COMMAND AUTHORITY OR OVERSEAS COMBATANT COMMANDER: The Contractor is not required to perform all services listed in this PWS during crisis.

2. SERVICES SUMMARY (SS): The Contract service requirements are summarized into performance objectives that relate directly to mission essential items. The performance threshold briefly describes the minimum acceptable levels of service required for each requirement.

Performance Objective

PWS Para Performance Threshold

SS# 1: Reference Laboratory Testing Services

1.1. Complete requirement 100% of the time.

SS# 2: Technical Data 1.2. Complete requirement 100% of the time

3. GOVERNMENT FURNISHED PROPERTY AND SERVICES:

3.1. UTILITIES: Testing will be performed outside of Misawa AB, therefore the Government will not supply any gas, electric, or water to the contractor in the performance of the work listed in this

PWS.

3.2. The Government will provide the following services for emergency purposes only:

a. Security Police Telephone 226-3600 (for emergency 911)

b. Fire Protection Telephone 911

c. Hospital Emergency Telephone 911

Any time the Contractor uses one of the above services on a cost reimbursement basis, the Contractor’s Contract Manager (CM) shall immediately report to the GR with all of the details.

4. PRIVACY AND CONFIDENTIALITY

4.1.1. PATIENT LISTS. Patient lists, no matter how developed shall be treated as privileged information. Lists and/or names of patients shall not be disclosed to or revealed in any way for any use outside the MTF without prior written permission by the Chief of Hospital Services.

4.1.2. PATIENT SENSITIVITY. Contract providers shall respect and maintain the basic rights of patients, demonstrating concern for personal dignity and human relationships. Providers receiving complaints validated by the Element Leader and Chief of the Medical Staff shall be subject to counseling and, depending on the nature and severity of the complaint, separation from performing services under this contract.

4.1.3. RELEASE OF MEDICAL INFORMATION. The healthcare worker shall only release medical information obtained during the course of this contract to other MTF staff involved in the care and treatment of that individual patient. All patient information will comply with HIPAA standards.

4.1.4. HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT (HIPAA) OF 1996: All individuals performing services at the 35th Medical Group are required to comply with local MTF HIPAA policies, and will be held accountable for complying with 35th Medical Group MDGI’s regarding health information privacy.

PRIVACY OF PROTECTED HEALTH INFORMATION

(a) Definitions. As used in this requirement:

Individual has the same meaning as the term ``individual'' in 45 CFR 164.501 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.

Required by Law has the same meaning as the term ``required by law'' in 45 CFR 164.501.

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

Terms used, but not otherwise defined, in this Contract shall have the same meaning as those terms in 45 CFR 160.103 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 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.

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

(f) 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.

(g) 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.

(h) 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.

(j) 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.

(k) 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 Requirement 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 Contract, the Contractor may use or disclose Protected Health Information on behalf of, or to provide services to, the Government for the following purposes, if such use or disclosure of Protected Health Information would not violate the Privacy Rule or the Department of Defense Health Information Privacy Regulation if done by the Government: [All purposes specified in Department of Defense Regulation 6025.18-R, Defense Health Privacy Regulation].

Specific Use and Disclosure Provisions

(a) Except as otherwise limited in this Contract, 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 Contract, 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 Contract, 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 164.502(j) (1).

Obligations of the Government

Provisions for the Government to Inform the Contractor of Privacy 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.

(c) The Government shall notify the Contractor of any restriction to the use or disclosure of Protected Health Information that the Government has agreed to in accordance with 45 CFR 164.522.

Permissible Requests by the Government

The Government shall not request the Contractor to use or disclose Protected Health Information in any manner that would not be permissible under the Privacy Rule if done by the Government, except for providing Data Aggregation services to the Government and for management and administrative activities of the Contractor as otherwise permitted by this requirement.

Termination

(a) Termination. A breach by the Contractor of this requirement, may subject the Contractor to termination under any applicable default or termination provision of this Contract.

(b) Effect of Termination.

(1) If this contract has records management requirements, the records subject to the Requirement should be handled in accordance with the records management requirements. If this contract does not have records management requirements, the records should be handled in accordance with paragraphs (2) and (3) below

(2) If this contract does not have records management requirements, except as provided in paragraph (3) of this section, upon termination of this Contract, for any reason, the Contractor shall return or destroy all Protected Health Information received from the Government, or created or received by the Contractor on behalf of the Government. This provision shall apply to Protected Health Information that is in the possession of subcontractors or agents of the Contractor. The Contractor shall retain no copies of the Protected Health Information.

3) If this contract does not have records management provisions and the Contractor determines that returning or destroying the Protected Health Information is infeasible, the Contractor shall provide to the Government notification of the conditions that make return or destruction infeasible. Upon mutual contract of the Government and the Contractor that return or destruction of Protected Health Information is infeasible, the Contractor shall extend the protections of this Contract to such Protected Health Information and limit further uses and disclosures of such Protected Health Information to those purposes that make the return or destruction infeasible, for so long as the Contractor maintains such Protected Health Information.

Miscellaneous

(a) Regulatory References. A reference in this Requirement to a section in the Privacy Rule means the section as in effect or as amended, and for which compliance is required.

(b) Survival. The respective rights and obligations of Business Associate under the ``Effect of Termination'' provision of this Requirement shall survive the termination of this Contract.

(c) Interpretation. Any ambiguity in this Requirement shall be resolved in favor of a meaning that permits the Government to comply with the Privacy Rule.