W81K0224Q0086-0001.pdf

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:

1. Extend the offer due date to Monday, 29 July 2024, 10:00 AM Haw aii Standard Time.

2. Change the IDC Type from “N/A” to “Indefinite Quantity” for CLINs 0001 – 4068.

3. Add FAR 52.204-29 Federal Acquisition Supply Chain Security Act Orders—Representation and Disclosures.

4. Incorporate revisions to PWS paragraphs 5.2.3, 5.3.2, 5.3.5, 5.3.17.7 and 5.3.18.3.

5. Respond to questions received.

1. CONTRACT ID CODE PAGE OF PAGES

J 1 16

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

16C. DATE SIGNED

BY 23-Jul-2024

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 W81K0224Q0086

X 9B. DATED (SEE ITEM 11)

10-Jul-2024

10B. DATED (SEE ITEM 13)

9A. AMENDMENT OF SOLICITATION NO.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

X The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offer X is extended, is not extended.

Offer must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended by one of the following methods:

(a) By completing Items 8 and 15, and returning 1 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN

REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE

CONTRACT ORDER NO. IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(B).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not, is required to sign this document and return copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

10A. MOD. OF CONTRACT/ORDER NO.

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

6. ISSUED BY

3. EFFECTIVE DATE

23-Jul-2024

CODE

W40M MRCO PACIFIC

MEDICAL READINESS CONTR OFC PACIFIC

BLDG 339 CLARK ROAD

FORT SHAFTER HI 96858-5098

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

4. REQUISITION/PURCHASE REQ. NO.

CODE

See Item 6

FACILITY CODECODE

EMAIL:TEL:

W81K0224Q0086

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 AND ANSWERS

Question 1: Paragraph 5.3.7: Can the responsibilities of the Government Representative to complete the Package Sample Shipping Document before shipping the ordered package samples to the contractor be more clearly defined in the contract including the Contract Item Number, Customer ID (Patient ID No.), Name, Gender, Quantity and etc.?

Answer 1: Paragraph 5.3.7 will remain same; the written order includes Name of Test, Patient Information, and Quantity.

Question 2: Paragraph 5.3.1: For Item No. 30, can the contractor complete the task by collecting samples from BDAACH, referring them to the Korean CDC, monitoring the results, and reporting to the COR?

Answer 2: No, based on market research, Filaria testing can be performed at local laboratories. There is no need for the testing to be referred to Korean CDC.

Question 3: Paragraph 5.3.1: Please provide the average annual historical number of tests per year requests for Item No. 30 (Filaria) of attachment 1 over the last three years.

Answer 3: The Government cannot provide historical number of tests for the last three years. Please see Attachment 1 for the annual estimated and maximum number of tests.

Question 4: Paragraph 5.3.2: Can the Time Frame for Testing Results for Clostridium difficile and G6PD be changed from 4 hours to 1 day due to commercial laboratory schedule work?

Answer 4: Yes, paragraph 5.3.2 has been updated to change the timeframe for testing results for Clostridium difficile and G6PD from 4 hours to 1 day.

Question 5: Paragraph 5.3.2: Please provide the average annual historical number per year of test orders for Clostridium difficile and G6PD over the last three years.

Answer 5: The Government cannot provide historical number of tests for the last three years. Please see Attachment 1 for the annual estimated and maximum number of tests.

Question 6: Paragraph 5.3.15: Please provide the average annual historical number per year of test orders for each contract item over the last three years.

Answer 6: The Government cannot provide historical number of tests for the last three years. Please see Attachment 1 for the annual estimated and maximum number of tests.

Question 7: Paragraph 5.3.16: Could you provide historical performance data per year for each item of Non- Routine/Rapid Turn-around Testing as mentioned?

Answer 7: No, the Government cannot provide historical performance data per year for Non-Routine/Rapid Turn-around Testing. Any test listed on the solicitation could be “Non-Routine/Rapid Turn-Around Testing” if any circumstances arise or per physician’s request. BDAACH laboratory performs initial screening testing in-house for any urgent requirement. After that, in order to confirm, BDAACH lab sends out specimen to the contractor for testing. It is rare to have a non-routine/rapid turn-around testing; BDAACH averages 2-3 emergency tests per year.

Question 8: Paragraph 5.3.16: Can you negotiate a separate rate under Korean law for non-routine/rapid turnaround testing, given the operational constraints on weekends and Korean holidays?

Answer 8: No, there is no need to have a separate rate for non-routine/rapid turnaround testing per the response to Question 7.

Question 9: Paragraph 5.3.17.7: Can you change the mandatory Specimen Retention period from 30 days to 14 days?

Answer 9: Yes, PWS paragraph 5.3.17.7 has been updated to change the mandatory specimen retention period from 30 days to 14 days.

SECTION SF 1449 - CONTINUATION SHEET

SOLICITATION/CONTRACT FORM

The required response date/time has changed from 24-Jul-2024 10:00 AM to 29-Jul-2024 10:00 AM.

SUPPLIES OR SERVICES AND PRICES

Global Changes

CLIN 0001 -- CLIN 4068

The IDC type has changed from N/A to Indefinite Quantity.

The following have been added by reference:

52.204-29 Federal Acquisition Supply Chain Security Act Orders--

Representation and Disclosures.

DEC 2023

The following have been modified:

PWS

PERFORMANCE WORK STATEMENT

FOR CLINICAL LABORATORY TESTING SERVICES

AT BRIAN D. ALLGOOD ARMY COMMUNITY HOSPITAL (BDAACH), KOREA

DEPARTMENT OF PATHOLOGY

TABLE OF CONTENTS

SECTION TITLE

1.0 INTRODUCTION

2.0 BACKGROUND

3.0 SCOPE OF WORK

4.0 QUALITY ASSURANCE SURVEILLANCE PLAN

5.0 REQUIRED SERVICES

6.0 APPLICABLE TECHNICAL ORDERS, SPECS, REGULATIONS, AND MANUALS

7.0 ACRONYMS AND DEFINITIONS

1.0. INTRODUCTION.

1.1. The contractor shall provide non-personal 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, 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 JC, 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. 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 6 Army clinics throughout the Korea Peninsula, Camp Casey Patient Centered Medical Home (PCMH) (DongDuChun), K-16 Health Clinic (Sungnam), 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).

Clinics offer routine laboratory testing and reference labs get transported to the BDAACH. BDAACH will disseminate special lab testing to reference laboratory locally or send them to a reference lab in US for complex lab tests.

3.0 SCOPE OF WORK.

3.1. The Contractor shall provide reference laboratory testing services to aid in the diagnosis and treatment for specimens submitted by the BDAACH, Department of Pathology. Services include the testing of specimens, and communication of results back to BDAACH to include 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. 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. RESERVED.

3.6. AT/OPSEC - Antiterrorism / Operations Security

3.6.1. AT Level I Training. This standard language is for contractor employees with an area of performance within an DHA-controlled installation, facility, or area. All contractor employees, including subcontractor employees, requiring access to DHHQ, Direct Reporting Markets (MTFs), Small Markets and Stand Alone (SSO) 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. This standard language is for contractor employees with an area of performance within a DHA controlled installation, facility, or area. 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, DHHQ 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. 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), applicable installation, facility and area commander installation/facility access and local security

3.6.4. iWATCH/Suspicious Activity Reporting Training. This standard language is for contractor employees with an area of performance within a DHA-controlled installation, facility, or area. The contractor and all associated subcontractors shall brief all employees on the local Suspicious Activity Training 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. MTF HOURS OF OPERATION

3.7.1. ACH’s and MEDCEN’s provide services 24 hours a day, 365 days a year (366 days during leap years) including holiday. Clinics have designated operating hours.

3.7.1.1. Laboratory Regular Hours: 0730 - 1630 (For outpatients), 24 hour 7 days a week including holiday for inpatient and emergency. Department of Pathology Shipping Hours are Monday – Friday, 0730 – 1630 (Korean Time).

3.7.2. 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. If the area in which a contract employee is scheduled to work is closed due to the holiday and the employee is not required to report in, payment will not be made for those hours. Closures of the installation due to inclement weather or other such acts of God shall be handled in the same manner.

3.7.3. Closures. During anticipated closure of the facility due to Command declared training holidays or during unplanned closure of the facility due to natural disasters, military emergencies, severe weather, or otherwise, the contractor shall not invoice the Government for services not performed and the Government will not be liable to the contractors for any such closures.

3.8. HOURS OF PERFORMANCE.

3.8.1. Scheduling Process: The Contractor shall complete work within times specified in Para 5.3.2 Mean Turn- Around Times, and notification shall be given if there is a delay.

3.8.2. The Contractor shall provide services Monday through Friday (Korean time), 0730 to 1630, excluding Korean holidays.

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

3.9. Conduct.

3.9.1. 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.

3.10. QUALITY MANAGEMENT

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

3.10.2. The Contractor shall ensure services meet 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.

4.0. QUALITY ASSURANCE SURVEILLANCE PLAN: See Attachment 2

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. Clinical Laboratory Testing Services. The Contractor and their subcontractor shall provide Reference Laboratory Testing services to include but not limited to, clinical and anatomic testing, pain management panels, treponema pallidum particle agglutination, Hepatitis B Surface Antibody Neutralization, renal biopsy and muscle biopsy testing, and pass through testing services. Services provided shall include 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.

5.1.2. Reports to: The COR, Department of Pathology, Brian D. Allgood Army Community Hospital

5.2. Qualifications.

5.2.1. Accreditation/License Requirements. The Contractor and/or their subcontractor 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 provide a current copy of CAP CLIA certificate with their quote.

5.2.2. Web Address. The Contractor and/or their subcontractor shall provide a secure web address for the test results to be checked. The website url shall begin with https://. The Contractor shall provide their secure url website and have a valid site certificate with their quote.

5.2.3. Designated Courier/Driver. The Contractor shall provide two (2) designated couriers/drivers for base access that are employed by the reference laboratory. Courier drivers shall not be subcontracted out. The couriers/drivers shall have a car/van with functioning A/C. This vehicle shall be utilized to transport the laboratory specimen within temperature-controlled coolers. The Contractor shall provide the two (2) names of the designated couriers/drivers with their quote.

5.2.4. The laboratory shall have a minimum of three (3) years of clinical laboratory experience in providing the required services to military medical treatment facilities or medical treatment facilities. The Contractor shall provide proof of three (3) years of clinical laboratory experience in providing the required services to military medical treatment facilities or medical treatment facilities with their quote.

5.3. Specific Duties/Tasks.

5.3.1. The reference lab shall provide 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, modifying test requests, 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 within the time frame set by the following schedule:

Testing Time Frame for Testing Result Clostridium difficile 1 day G6PD 1 day Routine Chemistry Tests 1 day Thyroid Hormone Assays 1 day for T3/T4, all others 2 weeks Pituitary Hormone Assays 1 week (except ADH, Free a, GH, Oxytocin, Somatostatin which are 3 weeks) Adrenal Cortex Hormones 3 weeks Tumor Markers 1 week (except a 1-Acidglycoprotein, CA 50, CA 130, CA 602 which are 3 weeks) Hepatitis Virus Antibodies l day Protein Electrophoresis 1 week Hematology Tests Microbiology Culture 1 week (except AFB Culture which is 4- 8 weeks) Viral Culture 30 days Molecular Diagnosis Infectious Gene PCR- 1 week Special Chemistry 1 week

All other turnaround time will be IAW its published Turnaround Time schedule in the reference lab’s Lab Manual, in compliance with the current standards published in the College of American Pathologist (CAP), Lab Accreditation Standards, Lab General Checklist.

5.3.3. Test. The reference lab shall provide the full range of clinical and anatomic pathology diagnostic testing capabilities to execute required tests defined in the Contractor’s Price List, and reference laboratory pass through services to other laboratories. All clinical reference laboratory testing shall be executed in accordance with standard industry practices and the College of American Pathologists (CAP). Reference Laboratory Testing services shall include but are not limited to, pain management panel, Treponema pallidum particle agglutination, Hepatitis B surface Antibody Neutralization, renal biopsy and muscle biopsy testing.

5.3.4. Test Menu (Commercial Catalog). On-line access to detailed reference data, such as might be normally available through a hardcopy Contractor reference manual, is required. The commercial catalog will be used by the Government as a reference to determine the specimen requirements, methodology and clinical utility of the tests offered by the contractor and/or their subcontractor. The catalog will not serve as a test price list or comprehensive list of tests available to the Government.

Test Categories Anatomic Pathology Chemistry Coagulation Endocrinology Flow Cytometry Hematology Histocompatibility Immunology Microbiology Molecular Pathology Mycology Reproductive Medicine Therapeutic Drug Monitoring Toxicology Transfusion Medicine Viral Markers Virology

5.3.5. The reference laboratory courier shall pick up laboratory specimens daily, Monday through Friday, with the exception of Korean Holidays, from the Department of Pathology, BDAACH. The Contractor shall provide the laboratory courier with specimen containers that are crush proof, leak proof, and labeled to indicate that they are medical specimens for diagnostic testing.

5.3.6. 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.

5.3.7. The Government shall package specimens for shipment and ensure specimens are accompanied by a written order specifying the tests to be performed.

5.3.8. The Contractor shall provide all required paperwork to obtain passes/vehicle decals to gain access to USAG- Humphreys.

5.3.9. If the Contractor anticipates a delay in sample testing they must contact the COR, Commercial Phone Number, 05033-37-7452.

5.3.10. The reference lab shall provide Department of Pathology, BDAACH with a list of all laboratory tests performed with Reference Ranges and test interpretations. Specimen handling instructions, minimum volumes, alias names, and any special instructions, such as required patient information or consent. The Contractor shall notify the COR within 2 weeks of any test interpretations changes and amended results reflecting those changes. Notification shall be made in writing.

5.3.11. The reference lab shall notify Department of Pathology, BDAACH Shipping 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.

5.3.12. 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.

5.3.13. 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.

5.3.14. The Contractor shall report within one day of notification of any change to its accreditation or certification status to the COR while performing under this contract.

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

5.3.15.1. 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.

5.3.15. Routine Specimen Testing.

5.3.15.1. Specimen Pickup. Daily courier service shall be provided Monday through Friday to include U.S.

Holidays, during the hours of 8:00 am through 12:00 pm to pick up specimens at the Department of Pathology, Shipping Section, BAACH. No routine pickup will be made on Saturdays, Sundays, or Korean Holidays.

5.3.15.2. Testing Time. With the exception of microbiological/cell culturing, the Contractor shall transmit a minimum of 90% of all final reports no later than 3:00 pm on the third working day after the day of pickup. For example, if 10 tests are picked up on Friday, at least nine (9) shall be reported before 3:00 pm the following Tuesday. The remaining 10% of these tests shall be reported within eight (8) working days. Cytogenetic test results shall be provided within 14 days of the day of pick-up.

5.3.15.3. Test Results. Test results shall be transmitted to the Department of Pathology terminal each weekday morning by 9:00 am and afternoon by 3:00 pm. The Contractor shall maintain a record of all tests results for the life of the contract.

5.3.16. Non-Routine/Rapid Turn-around Testing.

5.3.16.1. Specimen Delivery. The Contractor shall be available to accommodate testing that requires a rapid turnaround time testing 24 hours daily, Monday through Sunday, to include U.S. and Korean Holidays. The Government (Brian D. Allgood Army Community Hospital) shall be responsible for delivering these specimens for emergency or non-routine laboratory testing to the Contractor's testing facility. The contractor and/or their subcontractor shall provide a lab result within 1 hour of receipt of the specimen at the Contractor’s facility on Monday through Saturday. On Sunday and Korean Holiday, the contractor and/or their subcontractor shall provide a lab result within no later than four (4) hours of receipt of the specimen at the Contractor’s facility.

5.3.16.2. The reference lab shall provide rapid turn-around testing for the following tests 7 days a week, 24 hours a day, UA (including microscopic), Glucose, BUN, Creatinine, CK-MB, CPK, Na, K, Cl, CO2, Protein, Fibrinogen, CBC, PT, PTT, INR, Troponin, CBC, ALT, AST, Amylase, CSF protein & glucose, LDH, Carbon Monoxide, Acetaminophen, ethyl alcohol, gentamicin, vancomycin, salicylate, BNP, Magnesium and qualitative HCG.

5.3.16.3. Testing Time. All critical values (life threatening abnormal results) or those tests identified by the Department of Pathology, as requiring a quick turn-around time shall be telephonically reported directly to the Department of Pathology, Main Lab, or Shipping Section as soon as results are available, or within one hour of arrival at the testing facility on Monday through Saturday and within four (4) hours on Sunday and Korean Holiday whichever is shorter. The following telephone numbers will be used to report test results ONLY:

Commercial: 0503-337-7452 (Shipping)/7453 (Front Desk) or 0503-337-7452 (Shipping) / 7453(Front Desk). All quick turn-around time results reported telephonically shall be followed by a telefax report to Brian D. Allgood Army Community Hospital, Department of Pathology on the next normal workday.

5.3.17. Specimen Handling.

5.3.17.1. Tests requiring frozen specimens shall be kept frozen by the Contractor during transportation and shall arrive frozen at the Contractor test facility. No special preparation (other than providing the specimen in a frozen state) shall be required on the part of the Government.

5.3.17.2. 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.

5.3.17.3. Tests requiring specimens to be kept at room temperature shall be maintained at room temperature.

5.3.17.4. 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 the new specimen at no additional cost to the Government.

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

5.3.17.6. The Contractor shall submit documentation of its ground transport personnel indicating that they have satisfactorily completed training on transportation regulations of biohazards, notification procedures in case of accidents or spills, and patient confidentiality practice in compliance with local, DOD, and ROK regulations, every 3 years, to the COR.

5.3.17.7. Specimen Retention. Specimen must be stored for at least seven (7) days (thirty days in the case of serum specimens) after the reporting of results. In selected cases for other specimens and upon request by the Department of Pathology, the Contractor shall store a specimen(s) for up to 14 days at no additional cost. The Department of Pathology may request repeat determinations or add-on tests by telephone during the seven (or extended thirty) day period. Repeat determinations will be requested when test results do not fit the clinical picture of the patient and will be performed at no additional cost to the Government. Specimen retention applies to blood and serum specimens only.

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

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

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

5.3.18.1. The Contractor shall furnish a minimum of a 5-day supply of required test paraphernalia, which includes special test collection kits, Contact lab specific collection kits, and request forms within ten (10) working days after contract is awarded.

5.3.18.2. Laboratory Information and Management System. The Contractor shall use a computerized laboratory information and management system for rapid retrieval of results including any requested alteration (such as deleting or changing a test requisition) and assay information. The Contractor shall use appropriate terminal (hardware and software) and a letter quality printer to retrieve the results.

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

5.3.18.4. 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.

5.4. Requirements for all positions.

5.4.1. The Contractor shall ensure that all contract personnel providing services under this contract shall be able to read, write, and speak English well enough to effectively communicate with all parties and other health care providers. In addition, if the position requires the use of computers, the contract personnel shall be computer literate.

5.4.2. The contract personnel shall possess sufficient initiative, interpersonal relationship skills and social sensitivity such that he/she can relate constructively to a variety of patients from diverse backgrounds.

5.4.3 The contract personnel shall have the required education, training, experience and documented current competence in the required specialty position description.

5.4.4 Continuing Education. The Contractor shall ensure that contract personnel who are licensed, registered or certified by state bodies, professional organizations or national/medical associations continue to meet the minimum, standards for continuing education to remain current as prescribed by their professional agency and applicable regulatory guidelines and policies. The Contractor shall ensure contract personnel obtain continuing education at no additional cost to the Government. The Government may approve contract personnel to attend continuing education courses at the place of performance on a space available basis; however that time shall not be billable to the Government.

5.5. If services are provided remotely, the Contractor must adhere to all IT requirements for utilizing Government equipment and accessing Government systems. Supporting equipment will be at the vendor’s expense. i.e.

interfaces, hardware, and software.

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

Following is a list of basic publications applicable to this performance based statement of work. The Contractor is obligated to follow these publications.

Applicable Publications

Public Law:

Public Law 91-596 Occupational Safety and Health Act of 1970 Public Law 104-191 Health Insurance Portability and Accountability Act of 1996

Accreditation Manuals:

The Joint Commission (TJC) Manual (Current Edition)

Defense Health Agency:

DHA-AI 001 Telework Program DHA-AI 003 Physical Security Program DHA-AI 034 Drug-Free Workplace Program

DHA-AI 050 Accounting of Disclosures of Personally Identifiable Information (PII) and Protected Health Information (PHI)

DHA-AI 5015.01 Records Management DHA-AI 5200.02 Information Security Program DHA-AI 5200.03 Operations Security (OPSEC) Program

DHA-AI

DHAPI 6000.03 Life Support Training Certification Requirements and Guidance DHAPI 6010.02 MHS Prescription Drug Monitoring Program DHAPI 6015.02 Beneficiary Counseling and Assistance Coordinator (BCAC) and Debt Collection Assistance

Officer (DCAO) DHAPI 6025.04 Pain Management and Opioid Safety in the MHS DHAPI 6025.06 Standardized Templates for Primary Care Clinical Encounter Documentation DHAPI 6025.10 Standard Processes, Guidelines, and Responsibilities of the DoD Patient Bill of Rights and

Responsibilities in the Military Health System (MHS) Military Medical Treatment Facilities (MTFs)

DHAPI 6025.20 Medical Management (MM) Program within the Military Health System (MHS) DHAPI 6025.26 Standard Processes for the Military Health System (MHS) Nurse Advice Line (NAL) DHAPI 6025.27 Integration of Primary Care Behavioral Health (PCBH) Services into Patient-Centered Medical

Home (PCMH) and Other Primary Care Service Settings within the Military Health System

(MHS)

DHAPI 6025.28 Standard Processes and Procedures for Communication of Laboratory and Radiology Results DHAPI 6025.29 Provision of Human Immunodeficiency Virus (HIV) Pre-Exposure Prophylaxis (PrEP) for Persons at High Risk of Acquiring HIV Infection DHAPI 6025.33 Acupuncture Practice in Military Treatment Facilities DHAPI 6025.39 Medical Ethics in the Military Health System DHAPI 6025.42 Routine Adult Transthoracic Echocardiogram (TTE) Standards for all Military Medical Treatment

Facilities (MTFs) DHAPI 6040.07 Medical Coding of the DOD Health Record DHAPI 6401.01 Dental Sedation Medical Management DHAPI 6490.02 Behavioral Health (BH) Treatment and Outcomes Monitoring DHAPM 6025.01 Primary Care Behavioral Health (PCBH) Standards DHAPM 6025.13, Volumes 1-7 Clinical Quality Management in the Military Health System

Department of Defense (DoD):

DoD 5200.1-R Information Security Program DoD 5200.2 Personnel Security Program DoDI 5200.46 DoD Investigative and Adjudicative Guidance for Issuing the Common Access Card DoD 5210.42-R Nuclear Weapons Personnel Reliability Program (PRP) Regulation DoD 5400.7-R DoD Freedom of Information Act DoD 5400.11-R Department of Defense Privacy Program DoD 6010.13-M Medical Expense and Performance reporting System for Fixed Military Medical And Dental

Treatment Facilities Manual DoD 6010.15-M Military Treatment Facility Uniform Business Office (UBO) Manual DoD 6015.1-M Glossary of Healthcare Terminology DoD 6025.18-R DoD Health Information Privacy Regulation DoD 6055.5-M Occupational Medical Examinations and Surveillance Manual DoD 8580.02-R HIPAA Security Rule DoDD 5144.02 Information Technology Standards in the DoD DoDD 5205.2 DoD Operations Security (OPSEC) Program DoDD 5400.11 DoD Privacy Program DoDD 5500.07 Standards of Conduct DoDD 6000.14 Patient Bill of Rights and Responsibilities in the Military Health System (MHS) DODM 6025.13 Medical Quality Assurance (MQA) in the Military Health System (MHS) DoDD 6040.41 Medical Records Retention and Coding at Military Treatment Facilities

DoDD 6205.02E Policy and Program for Immunizations to Protect the Health of Service Members and Military Beneficiaries

DoDD 8190.3 Smart Card Technology DoDD 8500.01E Information Assurance DoDI 1100.22 Policy and Procedures for Determining Workforce Mix DoDI 1402.5 Criminal History Background Checks on Individuals in Child Care Services DoDI 3020.37 Continuation of Essential DoD Contractor Services During a Crises DoDI 5200.02 DoD Personnel Security Program (PSP) DoDI 6000.11 Patient Movement DoDI 6015.23 Delivery of Healthcare at Military Treatment Facilities: Foreign Service Care; Third Party

Collection; Beneficiary Counseling and Assistance Coordinators (BCACs) DoDI 6025.8 Ambulatory Procedure Visit (APV) DoDI 6025.13 Medical Quality Assurance (MQA) and Clinical Quality Management in the Military Health

System DoDM 6025.13 Medical Quality Assurance (MQA) and Clinical Quality Management in the Military Health

System (MHS) DoDI 6025.18 Privacy of Individual Identifiable Health Information in DoD Health Care Programs DoDI 6040.40 Military Health System Data Quality Management Control Procedures DoDI 6040.42 Medical Encounter and Coding at Military Treatment Facilities DoDI 6040.43 Custody and Control of Outpatient Medical Records DoDI 6205.2 Immunization Requirements DoDD 6459.01 Sexual Assault and Response (SAPR) Program

7.0. ACRONYMS AND DEFINITIONS.

AHLTA Armed Forces Longitudinal Technology Application AQL Acceptable Quality Level BAA Business Associate Agreement BLS Basic Life Support CAC Common Access Card CAF Central Adjudication Facility CDC Centers for Disease Control CE Continuing Education CFR Code of Federal Regulations CHBC Criminal History Background Check CHCS Composite Health Care System CLIN Contract Line Item Number CNACI Child Care National Agency Check with Inquiries COR Contracting Officer Representative CPARS Contractor Performance Assessment Reporting System DEA Drug Enforcement Administration DFARS Defense Federal Acquisition Regulation Supplement DHA Defense Health Agency DMHRSi Defense Medical Human Resources System - internet DoD Department of Defense DoDD Department of Defense Directive DoDI Department of Defense Instruction DTF Dental Treatment Facility e-QIP Electronic Questionnaires for Investigations Processing ERP Enterprise Resource Planning FAR Federal Acquisition Regulation FIPS PUB Federal Information Processing Standards Publication FTE Full-Time Equivalent FTR Federal Travel Regulation HIPAA Health Insurance Portability and Accountability Act of 1996

HSPD Homeland Security Presidential Directive IA Information Assurance IAW In Accordance With JTR Joint Travel Regulation KO…