Amendment 0003.pdf

W40M REGIONAL HEALTH CONTRACTING OF

REGIONAL HEALTH CONTR OFC PACIFIC

POC: JAYME C. NAGAO

BLDG 339 CLARK ROAD

FORT SHAFTER HI 96858-5098

0011694746

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 provide responses to questions received.

All other terms and conditions remain unchanged.

1. CONTRACT ID CODE PAGE OF PAGES

J 1 12

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

16C. DATE SIGNED

BY 30-Nov-2021

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 W81K0222Q0005

X 9B. DATED (SEE ITEM 11)

15-Nov-2021

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.

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

6. ISSUED BY

3. EFFECTIVE DATE

30-Nov-2021

CODE

W40M REGIONAL HEALTH CONTRACTING OF

REGIONAL HEALTH CONTR OFC PACIFIC

BLDG 339 CLARK ROAD

FT SHAFTER HI 96858-5098

W81K02 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE W81K02

FACILITY CODECODE

EMAIL:TEL:

W81K0222Q0005

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 30 - BLOCK 14 CONTINUATION PAGE

The following have been added by full text:

QUESTIONS & RESPONSES

1. Is it possible to change the Contractor’s Accreditation/License Requirements (Para 5.2.1) from “The Contractor and their subcontractors” to “The Contractor and/or their subcontractors”?

RESPONSE:

Paragraph 5.2.1 of the Performance Work Statement (PWS) has been revised to reflect, “Accreditation/License Requirements. The Contractor and/or their subcontractors shall be accredited and shall maintain its accreditation throughout the period of this contract by the College of American Pathologists (CAP) and/or Clinical Laboratory Improvement Amendments (CLIA). The Contractor shall report within one day of notification of any change to its accreditation or certification status to the Contracting Officer’s Representative (COR) while performing under this contract.”

Additionally, instances of “Contractor” has been updated to reflect “reference lab” throughout the PWS.

All changes to the PWS have been highlighted in yellow.

2. Is it possible to change the Contractor’s clinical laboratory experience requirements (Para 5.2.5) from “The

Contractor” to “The offeror”?

RESPONSE:

Paragraph 5.2.5 of the PWS has been revised to reflect, “The laboratory must have minimum three (3) years of clinical laboratory experience.”

Additionally, instances of “Contractor” has been updated to reflect “reference lab” throughout the PWS.

All changes to the PWS have been highlighted in yellow.

3. Do you have a current incumbent? And if so, what is the contract number?

RESPONSE:

This requirement is currently being performed under Contract No. W81K02-20-D-0017 that was awarded to Seoul Clinical Laboratories.

SECTION SF 1449 - CONTINUATION SHEET

The following have been modified:

PERFORMANCE WORK STATEMENT

PERFORMANCE WORK STATEMENT

COVID-19 TESTING

AT BRIAN D. ALLGOOD ARMY COMMUNITY HOSPITAL (BDAACH)

DEPARTMENT OF PATHOLOGY

TABLE OF CONTENTS

SECTION TITLE

1.0 INTRODUCTION

2.0 BACKGROUND

3.0 SCOPE OF WORK

4.0 QUALITY ASSURANCE

5.0 REQUIRED SERVICES

6.0 APPLICABLE TECHNICAL ORDERS, SPECS, REGULATIONS, AND MANUALS

7.0 ACRONYMS AND DEFINITIONS

1.0. INTRODUCTION.

1.1. This is a non-personnel services contract to provide clinical laboratory testing services for Brian D. Allgood Army Community Hospital (BDAACH), USAMEDDAC-Korea which shall contribute to a stable workforce tasked with providing quality health care services to a diverse beneficiary population. The Contractor shall provide all personnel, equipment, material, and supervision and any other items and services to perform clinical laboratory testing services as defined in this performance work statement for the Department of Pathology, BDAACH, US Army Garrison – Humphreys, An Jeong-Ri, Pyeongtaek, Kyonggi-Do, Republic of Korea.

1.2. All services shall be provided in accordance with established standards, principles and ethics of the profession and applicable professional specialty organizations, The Joint Commission (JC) standards, applicable Department of Defense (DoD) and Army specific regulations, directives, and policies, and military treatment facilities (MTF) specific policies, procedures, and job descriptions. The Contractor shall provide services in accordance with established principles and ethics of the medical profession, the national standards established by the TJC, the professional standards at the medical treatment facility (MTF), and the College of American Pathologists (CAP).

The Contractor shall be held accountable for compliance to the standards listed in the Comprehensive Accreditation Manual for Hospitals (CAMH) dated January 2020 or current version.

1.3. This contract is a non-personal services contract under which the personnel rendering the services are not subject, either by the contract’s terms or by the manner of its administration, to the supervision and control usually prevailing in relationships between the government and its employees.

2.0 BACKGROUND.

2.1. The mission of the military healthcare system (MHS) is to ensure the nation has available at all times a healthy military force supported by a combat ready healthcare system. Health care services for eligible MHS beneficiaries are provided at military treatment facilities (MTFs) located on or near military installations or posts. The military treatment facility may be a clinic, Hospital, or Medical Center. Clinics are outpatient facilities offering primary care or simple specialty care (routine exams, tests, treatments). The Clinic may be a stand-alone site or a satellite of a larger Clinic, Hospital, or Medical Center. Army Community Hospitals (ACH) offer more complex, resource-intensive secondary care (e.g. inpatient care, surgery under anesthesia) and primary care at outpatient clinics inside and outside the hospital. Army Medical Centers (MEDCENs) offer tertiary (sophisticated diagnosis/treatment of any ailment), secondary, and primary care, hospital services, preventive services, blood bank, and other services. In addition, all MEDCENs offer graduate medical education programs for physicians.

2.2. Brian D. Allgood Army Community Hospital (BDAACH) is located in Pyeongtaek, Kyonggi-Do, Republic of Korea. Our hospital provides inpatient, OR, General Surgery, outpatients and specialties clinics (ER, ICU, Internal Medicine, PICU/NICU, Immunizations and Adolescence clinic). We are the central hospital for 7 Army clinics throughout the Korea Peninsula, Camp Casey Patient Centered Medical Home (PCMH) (DongDuChun), K-16 Health Clinic (Sungnam), MSG Henry L. Jenkins Patient Centered Medical Home (PCMH) (Pyeongtaek), and SGT Shin Woo Kim Soldier Center Medical Home (SCMH) (Pyeongtaek) at USAG-Humphreys, Suwon Aid Station (Pyeongtaek), Camp Walker (Daegu), and Camp Carroll Health Clinic (Waegwan).

3.0 SCOPE OF WORK.

3.1. The reference lab will provide polymerase chain reaction (PCR)-based COVID-19 clinical testing services for specimens submitted by the Brian D. Allgood Army Community Hospital, Department of Pathology with a 24 hour turn-around time. Services include the pick-up and testing of specimens 7 days a week 365 days a year, and communication of results back to BDAACH via contractor’s website and hard copy results. Services shall be in accordance with the established principles, practices and ethics of the laboratory profession.

3.2 Administrative.

3.2.1. Contractor Representative. The Contractor shall designate, in writing, a primary point of contact for contract coordination and implementation not later than five business days after receiving notice of contract award. Changes in the primary point of contact (POC), at any time, shall require the Contractor to notify the Contracting Officer (KO) of the new representative at least five working days prior to the change. This notification shall be in writing and shall state the name and contact information for the new point of contact.

3.2.2. The Contracting Officer’s Representative (COR) will be the KO’s authorized representative in administering the contract at the MTF level. The Contractor’s representative shall be available to discuss any problems that the Contractor’s personnel may be experiencing during the performance of this contract. Problems experienced by the Government with the Contractor’s performance will be discussed and resolved. Unresolved problems will be referred to the KO for resolution.

3.2.3. The use of non-compete conditions in employment agreements or in subcontracts (to prevent loss of personnel by the contractor) effective only during the period of the contract performance is acceptable. However, the use of non-compete conditions in employment agreements and/or in subcontracts that prevent employees and/or subcontractors of the incumbent from being interviewed by, employed, or accepting offers of employment and/or subcontracts by the new contractor on the follow-on contracts is unacceptable. It hinders the government’s ability to accomplish the mission of providing medical care to beneficiaries. Inclusion of such conditions in an employer’s employment agreement and/or subcontracts will result in an offeror’s proposal being unacceptable. Awardee, and their subcontractors, may not include such conditions in employment agreements and/or subcontracts while performing under this contract.

3.2.4. The Contractor and contract personnel shall abide by all MTF standards, rules, and procedures including requirements for any licensure, credentialing and quality assurance requirements. Such regulations include, but are not limited to, general safety, fire prevention, waste disposal, infection control, JC, and patient safety initiatives.

3.2.5. Media and Other Inquiries. The Contractor shall not respond to any media inquiries. Any inquiries from the media, third parties, or public agencies shall be immediately relayed to the COR, who will relay them to the MTF Public Affairs Officer or, after duty hours, to the Administrative Officer of the Day (AOD). There shall be no interviews, comments, or any other response without the knowledge and approval of the MTF Commander. Other than routine inquiries from external agencies, all other inquiries and complaints shall be brought to the attention of the COR.

3.3. Conflict of Interest.

3.3.1. The Contractor or contract personnel shall not bill the patient for services rendered under this contract. The

Contractor or contract personnel shall not request or accept compensation of any kind for patients treated, procedures performed, or any other actions performed, except under the terms and conditions of this contract, at the rate specified.

3.3.2. The Contractor or contract personnel shall not, while performing services under this contract, advise, recommend, or suggest to persons eligible to receive medical care at Government expense that such persons should receive care from the Contractor or contract personnel or from any third party at any place other than as designated under this contract.

3.3.3. Confidentiality of Information. Unless otherwise specified, all financial, statistical, personnel, and/or technical data which is furnished, produced or otherwise available to the Contractor during the performance of this contract are considered confidential business information and shall not be used for purposes other than performance of healthcare services under this contract. The Contractor shall not release any of the above information without prior written consent of the KO. The Contractor/contract personnel shall not use patient care rendered pursuant to this contract as part of a study, research project, or publication. The contract personnel shall prepare medical records, forms and documents as required, in accordance with the regulations and established guidelines listed in the contract.

3.3.4. The Contractor shall not employ active duty military or Government civilian employees to perform services under this contract.

3.3.5. The Contractor or contract personnel shall not use Government facilities, supplies, or equipment in private practice or for any purpose other than providing the healthcare services required under this contract.

3.4. Security.

3.4.1. RESERVED.

3.4.2. Safeguarding Material. The contract personnel shall be responsible for safeguarding all Government property.

The Contractor shall safeguard information of a confidential or sensitive nature. All patient related information is considered confidential and sensitive. If working remotely, Contractors are prohibited from reproducing patient information in any way. This includes printing. Neither the Contractor nor any of its contract personnel shall disclose or cause to be disseminated any information concerning the operation of the MTF that could result in or increase the possibility of a breach in security or interrupt the continuity of operations or which breach the requirements of the Federal Privacy Act of 1974. However, the Contractor may be required to provide testimony or disposition in cases of due process action.

3.5. POLICY FOR REPORTING INCIDENTS OF SEXUAL ASSAULT AND SEXUAL HARASSMENT UNDER

SEXUAL ASSAULT PREVENTION AND RESPONSE PROGRAM (SHARP).

3.5.1. The contractor shall comply with OTSG/MEDCOM Policy Memo 19-019, Sexual Harassment/Assault Response and Prevention (SHARP) Program, Mar 21, 2019. The SHARP reporting requirements apply only to knowledge obtained by contractor personnel while performing services under this contract.

3.5.2. The contractor shall require all contract personnel 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.

3.5.3. The contractor shall require all contract personnel 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 contract personnel or Government personnel, or other individuals.

3.6. AT/OPSEC - Antiterrorism and Operations security

3.6.1. AT Level I Training. All contractor employees, to include subcontractor employees, requiring access Army installations, facilities and controlled access areas shall complete AT Level I awareness training within 30 calendar days after contract start date or effective date of incorporation of this requirement into the contract, whichever is applicable and annually thereafter. The contractor shall submit certificates of completion for each affected contractor employee and subcontractor employee, to the COR or to the contracting officer, if a COR is not assigned, within 05 calendar days after completion of training by all employees and subcontractor personnel. AT level I awareness training is available at the following website: http://jko.jten.mil

3.6.2. Access and General Protection/Security Policy and Procedures. Contractor and all associated sub-contractors employees shall provide all information required for background checks to meet installation access requirements to be accomplished by installation Provost Marshal Office, Director of Emergency Services or Security Office.

Contractor workforce must comply with all personal identity verification requirements (FAR clause 52.204-9, Personal Identity Verification of Contractor Personnel) as directed by DOD, HQDA and/or local policy. In addition to the changes otherwise authorized by the changes clause of this contract, should the Force Protection Condition (FPCON) at any individual facility or installation change, the Government may require changes in contractor security matters or processes.

3.6.3. For contractors that do not require CAC, but require access to a DoD facility or installation. The Contractor and all associated sub-contractors employees shall comply with adjudication standards and procedures using the National Crime Information Center Interstate Identification Index (NCIC-III) and Terrorist Screening Database (TSDB) (Army Directive 2014-05/AR 190-13), applicable installation, facility and area commander installation/facility access and local security policies and procedures (provided by government representative), or at OCONUS locations, in accordance with status of forces agreements and other regulations.

3.6.4. iWATCH Training. The Contractor and all associated sub-contractors shall brief all employees on the local iWATCH program (training standards provided by the requiring activity ATO). This locally developed training will be used to inform employees of the types of behavior to watch for and instruct employees to report suspicious activity to the COR. This training shall be completed within 30 calendar days of contract award and within 05 calendar days of new employees commencing performance with the results reported to the COR NLT 30 calendar days after contract award.

3.7. ACCOUNTING FOR CONTRACTOR SUPPORT: The contractor shall report ALL contractor labor hours (inclusive of subcontractor labor hours) required for performance of services provided under this contract via a secure data collection site. Reporting shall be accomplished online by going to web address: http://www.SAM.gov/, and then clicking on the “Service Contract Report” section of SAM. The reporting period is the period of performance not to exceed 12 months ending September 30 of each government fiscal year and must be reported by 31 October of each calendar year. The contractor shall notify the Contracting Officer’s Representative (COR) by the 5th working day of November whether or not they have completed this report. If the COR is unavailable, the contractor will notify the Contracting Officer.

3.8. MTF HOURS OF OPERATION

3.8.1. Department of Pathology Shipping Hours are Monday – Friday, 0730 – 1715 (Korean Time).

3.8.1.1. Laboratory Regular Hours: 0730 - 1715 (For outpatients), 24 hour 7 days a week including holiday for inpatient and emergency.

3.8.2. Holidays. The following is a list of legal federal holidays. Any of the federal holidays falling on a Saturday will be observed on the preceding Friday, holidays falling on a Sunday will be observed on the following Monday.

Contract personnel may be required to work on legal holidays as determined by the COR.

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 Juneteenth, June 19th 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 holidays that are declared by Presidential Executive Order shall be observed in the same manner as the holidays listed above.

3.9. HOURS OF PERFORMANCE.

3.9.1. The Contractor is expected to be open for services 24 hours a day, 7 days a week to include U.S and Korean holidays.

3.9.2. The Contractor is responsible for ensuring that any alternate accommodations must include/perform the following:

3.9.2.1. The Contractor assumes all material and financial liability, regardless of any alternate accommodated carrier(s), in the event the package(s) is/are damaged in transit after they are picked up from the Customer.

3.9.3. The Contractor is responsible for submitting an accurate invoice.

3.10. Conduct.

3.10.1. Contract personnel shall comply with MTF policies regarding personal appearance and conduct when on-site at the MTF performing their contract related duties.

3.10.2. Contract personnel shall abide by federal, state, and local MTF regulations and requirements concerning the nature of limited privileged communication between patients and the contract personnel as may be necessary for security and personnel reliability programs. They shall also abide by federal, state, and local MTF regulations concerning the confidentiality of patient records, as embodied in federal statutes including the Privacy Act of 1974 and the Health Insurance Portability and Accountability Act (HIPAA) of 1996. All medical records and reports will remain the property of the Government.

3.11. QUALITY MANAGEMENT

3.11.1 The Contractor shall have a planned and systematic quality management process for monitoring and analyzing its contract performance.

3.11.2. The Contractor shall ensure that all contract employees comply with the MTF quality management/process improvement activities.

3.12. TRUSTED ASSOCIATED SPONSORSHIP SYSTEM (TASS).

3.12.1. The Contractor shall comply with agency personal identity verification procedures that implement Homeland Security Presidential Directive-12 (HSPD-12), Office of Management and Budget (OMB) guidance M-05-24, and Federal Information Processing Standards Publication (FIPS PUB) Number 201.

3.12.2. The Contractor shall comply with agency personal identity verification procedures in all subcontracts when the subcontractor is required to have physical access to a federally controlled facility or access to a Federal information system.

3.12.3. The Contractor shall ensure compliance with the provisions set forth below. For purposes of the Federal Acquisition Regulation (FAR) Clause 52.204-9, the USG will designate a Trusted Agent (TA) for this contract. The USG reserves the right to amend or supplement these provisions pursuant to the Changes clause in the contract.

4.0. QUALITY ASSURANCE SURVEILLANCE PLAN. See Attachment 1.

4.1. Inspection. The inspection and acceptance point for all services rendered under this contract will be the COR.

The performance by the contract personnel, the quality of services rendered, and any documentation or written material in support of same, shall be subject to continuous inspection, surveillance and review for acceptance by the KO or COR. Any services rendered by the contract personnel to patients or interaction with military/civilian personnel deemed unprofessional, threatening, or dangerous by the KO will be grounds for immediate termination for default or cause. Quality Assurance procedures established by the MTF shall be used for continuous monitoring.

Other performance evaluation factors will be monitored that are not quantified by numerical measurements which include: Contractor providing personnel not meeting the minimum qualification standards; inappropriate prescriptions; patient customer service comments; Contractor relationship with hospital staff/Government contracting personnel; compliance with hospital healthcare policies and procedures.

4.1.1. The quality for services rendered hereunder shall conform to best practices and the highest standards in Clinical Laboratory Medicine. The Contractor’s laboratory operations must conform to best practice requirements as outlined by the College of American Pathologist (CAP) (inspection checklists – most current edition) or other Clinical Laboratory Improvement Amendments (CLIA) approved accreditation agency’s checklist or inspection criteria, which are hereby incorporated by reference with the same force and effect as if set forth in full text.

4.1.2. The Contractor shall ensure the accurate and timely performance of laboratory testing services in biologic specimens provided by Submitting Activities (SA). The quality for all services rendered hereunder shall conform to the highest standards in the clinical pathology and clinical reference laboratory professions. Such standards and operating manuals shall include the procedures as outlined in the College of American Pathologist (CAP) Inspection Checklists (current edition) which are hereby incorporated by reference with the same force and effect as if set forth in full text.

5.0. REQUIRED SERVICES.

5.1. The Contractor shall provide once daily, seven day a week courier service for the pick-up of samples from BDAACH. Additionally, the reference lab shall provide polymerase chain reaction (PCR)-based COVID-19 clinical testing for up to 3,000 samples per day within 24 hours turnaround time from the time of delivery to the laboratory.

The reference lab shall perform the PCR-based COVID-19 clinical testing in Korea. Services provided shall include the laboratory providing testing, supplies, labor, customer services, courier services, software, information technology, reporting/interpreting, resulting reporting, and management reports.

5.1.1. Place of Performance: All tests shall be executed at the Contractor’s premises, or within the Contractor’s network of laboratories in Korea.

5.1.2. Hours of Performance: The reference lab is expected to be open for services 24 hours a day, 7 days a week, 365 days per year to include U.S. and Korean holidays.

5.1.3. Reports to: The COR

5.2. Qualifications.

5.2.1. Accreditation/License Requirements. The Contractor and/or their subcontractors shall be accredited and shall maintain its accreditation throughout the period of this contract by the College of American Pathologists (CAP) and/or Clinical Laboratory Improvement Amendments (CLIA). The Contractor shall report within one day of notification of any change to its accreditation or certification status to the Contracting Officer’s Representative (COR) while performing under this contract.

5.2.2. Location of Testing. The laboratory shall be located in Korea.

5.2.3. Web Address. The Contractor shall provide a web address for the test results be checked. The website url shall begin with https://. The Contractor shall provide their secure url website with their quote.

5.2.4. Designated Courier/Driver. The Contractor should provide name of designated couriers/drivers. The couriers/drivers should have a car/van with functioning A/C. This vehicle shall be utilized to transport the laboratory specimen within temperature-controlled coolers.

5.2.5. The laboratory must have minimum three (3) years of clinical laboratory experience.

5.3. Specific Duties/Tasks.

5.3.1. The reference lab shall provide qualified technical personnel who shall be available by telephone 24 hours a day, 7 days a week, to assist the Department of Pathology staff in obtaining test results, and obtaining information regarding tests and test services and resolving test related problems.

5.3.2. The reference lab shall provide test results in English for all tests performed in-house and at separate locations within the Contractor’s Organization, within a 24 hour turn-around time starting when the samples are received at the testing facility.

5.3.3. Capability of Test. The reference lab shall perform PCR-based clinical reference laboratory testing services for COVID-19 in Korea. The reference lab shall be capable of performing clinical testing up to 3,000 samples a day and shall provide results within the established 24 hour turn-around time. All clinical reference laboratory testing shall be executed in accordance with standard industry practices and the College of American Pathologists (CAP) standards.

5.3.4. The Contract courier shall come to Department of Pathology, BDAACH between 1300-1900 daily, Monday through Sunday, to include U.S and Korean Holidays to pick up samples. The Contractor shall provide the courier with specimen containers that are crush proof, leak proof, and labeled to indicate that they are medical specimens for diagnostic testing.

5.3.5. The Contractor shall provide the temperature-controlled coolers to maintain temperature integrity. The government shall provide materials to maintain designated temperature requirement such as dry ice, gel pack, etc.

5.3.6. The Government shall package specimens for shipment and ensure specimens are contained in a tube with patient information including patient name and patient identification number, and accompanied by a written order specifying the tests to be performed.

5.3.7. The Contractor shall provide all required paperwork to obtain passes/vehicle decals to gain access to USAG- Humphreys to come to the laboratory.

5.3.8. If the Contractor anticipates a delay in sample testing they must contact the Department of Pathology, BDAACH at 05033-37-7471. Point of Contact is Chief of Microbiology or COR, Commercial Phone Number, 05033-37-7470.

5.3.9. The reference lab shall provide Department of Pathology, BDAACH with a list of all laboratory tests performed and test interpretations. Specimen handling instructions, minimum volumes, alias names, and any special instructions, such as required patient information or consent. The reference lab shall notify Department of Pathology, BDAACH within 2 weeks of any changes to testing methodology or test interpretations. Notification shall be made in writing.

5.3.10. The reference lab shall notify Department of Pathology, BDAACH Microbiology section of any testing discrepancies identified after initial reporting of patient results. Documentation shall include the affected specimen(s), description of the discrepancy, and the corrective action(s) taken to remedy the situation.

5.3.11. The Contractor shall ensure work meets quality and timeliness requirements specified in this contract, to include scheduling change(s) of technicians, courier services and responding to critical requirements such as emergency contingencies.

5.3.12. The Contractor shall ensure all laboratory facilities used to perform the requirements of this contract meet and maintain all certification(s), accreditation(s), license(s) etc. required when executing performance under this contract.

5.3.13. Specimen Delivery. The reference lab shall be available to accommodate high volumes of PCR-based COVID-19 clinical testing for up to 3,000 samples per day. The contractor shall provide 7 day a week, 365 day a year testing and shall provide results within a 24 hour turn-around time.

5.3.14. Specimen Handling.

5.3.14.1. Tests requiring refrigerated specimens shall be maintained at 2-8 degrees Centigrade during transportation and will arrive refrigerated at that temperature at the contractor facility.

5.3.14.2. Any specimens that have been broken, leaked, or otherwise compromised during transit shall be reported to the Department of Pathology, immediately upon unpacking at the Contractor's site. The Contractor shall be required to pick up new specimen(s) at no additional cost to the Government.

5.3.14.3. When transporting biological specimens, the Contractor shall follow all U.S. Government and Korean Regulations and requirements while transporting specimens on and off post.

5.3.14.4. Accuracy. The reference lab shall subscribe to all applicable proficiency testing per accreditation standards. In the event of repeated questionable accuracy of a given analyte, the Contractor shall provide the total number of challenges and responses obtained on the most recent proficiency testing of the analyte, and demonstrate that there are no consecutive failures. If requested, the reference lab will submit to split-testing with other reference laboratories. Results will not vary by more than 10% with other reference laboratories.

5.3.14.5. Test Results. Test result information shall also be available on-line through "patient information" record.

5.3.15. Contractor Furnished Supplies, Equipment, and Personnel Resources.

5.3.15.1. The reference lab shall provide all lab results through internet or hard copy, if internet is not possible.

5.3.15.2. Reference Manual containing detailed reference data, such as might be normally available through a hard copy contractor reference manual is required. Such data shall include; test description and its requirements, methodology used to perform the test, schedule for test performance (if any), and date the test was last changed.

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

Following is a list of basic publications applicable to this performance based statement of work. Additional publications may be listed by call. The Contractor is obligated to follow these publications. Current issues of Army publications and links to other service publications can be accessed at http://www.apd.army.mil/. Army publications not on the internet or MTF policies and procedures can be obtained from the MTF. Department of Defense publications can be found at www.defenselink.mil/pubs or www.dtic.mil/whs/directives.

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.

Mandatory Publications:

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 Current Edition Joint Commission for Accreditation of Healthcare Organizations (JCAHO) Manual AR 25-2 Information Assurance AR 40-1 Composition, Mission, and Functions of the Army Medical Department AR 40-3 Medical Services: Medical, Dental, and Veterinary Care AR 40-4 Army Medical Department Facilities/Activities AR 40-5 Preventive Medicine AR 40-66 Medical Records Administration and Health Care Documentation AR 40-330 Rates Codes, Expense and Performance Reporting Systems, Centralized, Billing, and Medical Service Accounts AR 40-400 Patient Administration AR 40-407 Nursing Records and Reports AR 40-501 Standards of Medical Fitness AR 40-562 Immunizations and Chemoprophylaxis AR 340-21 The Army Privacy Program AR 380-5 Department of Army Information Security Program AR 380-53 Information Systems Security Monitoring AR 380-67 The Department of the Army Personnel Security Program AR 385-40 Accident Reporting and Records and HSC Supplements AR 608-18 Army Family Advocacy Program AR 600-85 Alcohol & Drug Abuse Prevention and Control Program MEDCOM Pam 25-31 Index of Command Administrative Publications DA PAM 40-11 Preventive Medicine DoD 6055.5-M Occupational Medical Surveillance Manual TG 149 Guidelines for Controlling Occupational Exposure to Hazardous Drugs TG 190 Guide to Managing Exposure to Bloodborne Pathogens TB MED 510 Guidelines for the Recognition Evaluation, and Control of Occupational Exposure to Waste Anesthetic Gases Advisory Publications.

AMA CPT Physician’s Current Procedural Terminology, updated annually See https://catalog.ama.assn.org TB Med 2 Sterilizing Medical, Surgical, Dental, and Veterinary Material AR 40-501 Medical Examinations AR 190-13 The Army Physical Security Program AR 608-1 Army Community Service Program DA Pam 25-51 The Army Privacy Program: System Notices and Exemptions Rule DoD 1341.2-M DEERS Program Manual DoDD 5200.2 DoD Personal Security DoD 6010.8-R Civilian Health and Medical Program of the Uniformed Services CHAMPUS, Ch 9, 1 Jul FM 3-19.30 Physical Security PL 89-614 Chapter 55, 10 U.S.C. (1071-1088) Title 29, CFR Occupational Safety and Health Standards DHA-PM 6025.13 Clinical Quality Management in the Military Health System, Volume 4 Credentialing and Privileging Current issues of many forms can be accessed at http://www.usapa.army.mil/forms

7.0. ACRONYMS AND DEFINITIONS.

ADM - Ambulatory Data Module

ADS - Ambulatory Data System AHA - American Hospital Association AHLTA - Armed Forces Health Longitudinal Technology Application AKO - Army Knowledge Online AMA - American Medical Association AOD - Administrative Officer of the Day AR - Army Regulation CAC - Common Access Card CAMH - Comprehensive Accreditation Manual for Hospitals CFR - Code of Federal Regulations CHCS - Composite Health Care System CLIN - Contract Line Item Number COR - Contracting Officer's Representative COTR - Contracting Officer’s Technical Representative CPT - Current Physicians Terminology CVS - Contractor Verification System DA - Department of the Army DoD - Department of Defense DODI - Department of Defense Instruction EFT - Electronic Funds Transfer FAR - Federal Acquisition Regulation FSO - Facility Security Officer FTE - Full Time Equivalent HCP - Healthcare Provider HIPAA - Health Insurance Portability & Accountability Act of 1996 LADS - Labor and Delivery Statistics System MEDCENs - Army Medical Centers MEDCOM - Medical Command MHS - Military Healthcare System JC - The Joint Commission KO - Contracting Officer MTF - Medical Treatment Facility OIC - Officer in Charge OSHA - Occupational Safety and Health Administration PAM - Pamphlet PAR - Performance Assessment Report POC - Point of Contact PWS - Performance Work Statement PL - Public Law QASP - Quality Assurance Surveillance Plan QC - Quality Control RVU - Relative Value Units SF - Standard Form TA - Trusted Agent TAMC - Tripler Army Medical Center UCAPERS - Uniform Charts of Accounts Personnel System

END OF PERFORMANCE WORK STATEMENT

(End of Summary of Changes)