W81K0224Q0099-0002.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. Incorporate revisions to PWS paragraphs 3.7.1.1, 3.8.1, 3.8.2.1, 3.10.1, 3.10.2, 5.1.2.1, 5.1.2.2, and 5.1.3 – 5.2.4.

2. Incorporate new PWS paragraphs 5.1.2.3, 5.1.2.4 and 5.1.3.2.1.

3. Respond to questions received.

1. CONTRACT ID CODE PAGE OF PAGES

J 1 13

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

16C. DATE SIGNED

BY 04-Aug-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 W81K0224Q0099

X 9B. DATED (SEE ITEM 11)

22-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 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

04-Aug-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:

W81K0224Q0099

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: Can you confirm that the multi-gene method is acceptable to perform all of your required first and second tests?

Answer 1: A multi-gene method is acceptable if the requirements of 5.1.3.1 – 5.1.3.10 are met.

Question 2: Can you change the PWS paragraphs 5.1.2.1, 5.1.2.2, and 5.1.3 – 5.2.4 from "The Contractor and its subcontractors" to "The Contractor and/or its subcontractors"?

Answer 2: PWS 5.1.2.1, 5.1.2.2 and 5.1.3 – 5.2.4 have been revised. New paragraphs 5.1.2.3, 5.1.2.4 and 5.1.3.2.1 have been added.

Question 3: Regarding the Addendum to 52.212-1, Volume I – Administrative (d): The quoter shall submit a statement which attests that the quoter and all subcontractors shall already have, OR confirm the ability to obtain the requisite business licenses directly from the ROK Government, and conduct business in accordance with all applicable ROK laws, including but not limited to, rules and policies regarding labor, taxation, and immigration. If an initial quote does not fully demonstrate this authorization and capacity, it will not be further considered for award.

Is this language new, and what is the applicability to the required services?

Answer 3: This standard language was added in February 2022, and is applicable to Government contracts performed in the Republic of Korea.

SECTION SF 1449 - CONTINUATION SHEET

The following have been modified:

PWS

PERFORMANCE WORK STATEMENT

FOR NEWBORN SCREENING TESTING

DEPARTMENT OF PATHOLOGY

BRIAN D. ALLGOOD ARMY COMMUNITY HOSPITAL, KOREA

TABLE OF CONTENTS

SECTION TITLE

1.0 INTRODUCTION

2.0 BACKGROUND

3.0 SCOPE OF WORK

4.0 QUALITY ASSURANCE SURVEILLANCE PLAN

5.0 SERVICE DESCRIPTION

6.0 APPLICABLE TECHNICAL ORDERS, SPECS, REGULATIONS, AND MANUALS

7.0 ACRONYMS AND DEFINITIONS

1.0. INTRODUCTION.

1.1. The Contractor shall provide the non-personal services of newborn screening testing for Brian D. Allgood Army Community Hospital (BDAACH), 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 newborn screening testing services as defined in this performance work statement for the Department of Pathology, BDAACH, 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 all personnel, equipment, material, and supervision and any other items and services to perform newborn screening testing services as defined in this performance work statement for the Department of Pathology, BDAACH, Pyeongtaek, Kyonggi-do, Republic of Korea.

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 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.

3.2.4. 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. RESERVED.

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: 7:30am- 4:30pm (For outpatients), 24 hour 7 days a week including holiday for in-patient 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.

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. Closures of the installation due to inclement weather or other such acts of God shall be handled in the same manner.

3.8. HOURS OF PERFORMANCE.

3.8.1. Scheduling process: The reference laboratory shall complete work within turn-around times specified in the contractor’s Lab Manual, and notification will be given if there is a delay.

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

3.8.2.1. The Contractor may only invoice and be paid for the services actually rendered. If the Contractor or their subcontractor performs fewer services than are provided in the contract schedule, the Government may, at the end of the applicable contract period, deobligate the excess quantities.

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

3.10.2. The Contractor and subcontractor 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. PERFORMANCE REQUIREMENTS SUMMARY: 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.

5.0. SERVICE DESCRIPTIONS.

5.1. Required Services: Newborn Screening Testing

5.1.1. Reports to: COR, Department of Pathology, Brian D. Allgood Army Community Hospital (BDAACH)

5.1.2. Qualifications:

5.1.2.1. Accreditation/License Requirements. The Contractor or their subcontractor shall be accredited and shall maintain accreditation throughout the period of this contract by the College of American Pathologists (CAP) or by The Joint Commission (JC). The Contractor or subcontractor 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.

5.1.2.2. The Contractor or subcontractor shall have a minimum two (2) years of clinical laboratory experience.

5.1.2.3. 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 Contractor shall provide the two (2) names of the designated couriers/drivers with their quote.

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

5.1.3. Specific Duties/Tasks:

5.1.3.1. The Contractor or their subcontractor shall follow the US Department of Health & Human Services Secretary's Advisory Committee on Heritable Disorders in Newborns and Children (SACHDNC), Recommended Uniform Screening Panel for Newborns, in order to screen every infant for the following disorders:

The Contractor or their subcontractor shall at a minimum provide ALL of the tests listed below for 1st and 2nd Screening:

1st Screen: Performed 24–48 hours of age or at discharge, whichever comes first -

Amino Acid Disorders

• Argininemia (ARG)

• Argininosuccinic aciduria (ASA)

• Citrullinemia, type I (CIT)

• Citrullinemia, type II (CIT II)

• Phenylketonuria (PKU)

• Homocystinuria (HCY)

• Hypermethioninemia (MET)

• Maple syrup urine disease (MSUD)

• Tyrosinemia, type I (TYR I)

• Tyrosinemia, type II (TYR II)

Endocrine Disorders

• Congenital adrenal hyperplasia (CAH)

• Primary congenital hypothyroidism (CH)

Fatty Acid Oxidation Disorders

• Carnitine acylcarnitine translocase deficiency (CACT)

• Carnitine palmitoyltransferase I deficiency (CPT-IA)

• Carnitine palmitoyltransferase type II deficiency (CPT-II)

• Carnitine uptake defect (CUD)

• Glutaric acidemia, type II (GA-2)

• Long-chain L-3 hydroxyacyl-CoA dehydrogenase deficiency (LCHAD)

• Medium-chain acyl-CoA dehydrogenase deficiency (MCAD)

• Short-chain acyl-CoA dehydrogenase deficiency (SCAD)

• Trifunctional protein deficiency (TFP)

• Very long-chain acyl-CoA dehydrogenase deficiency (VLCAD)

Hemoglobin Disorders

• Hemoglobinopathies (Var Hb)

• S, Beta-thalassemia (Hb S/ßTh)

• S, C disease (Hb S/C)

• Sickle cell anemia (Hb SS)

Organic Acid Conditions

• 2-Methyl-3-hydroxybutyric acidemia (2M3HBA)

• 2-Methylbutyrylglycinuria (2MBG)

• 3-Hydroxy-3-methylglutaric aciduria (HMG)

• 3-Methylcrotonyl-CoA carboxylase deficiency (3-MCC)

• 3-Methylglutaconic aciduria (3MGA)

• Beta-ketothiolase deficiency (BKT)

• Glutaric acidemia type I (GA1)

• Holocarboxylase synthetase deficiency (MCD)

• Isobutyrylglycinuria (IBG)

• Isovaleric acidemia (IVA)

• Malonic acidemia (MAL)

• Methylmalonic acidemia (cobalamin disorders) (Cbl A,B)

• Methylmalonic acidemia (methymalonyl-CoA mutase deficiency) (MUT)

• Methylmalonic acidemia with homocystinuria (Cbl C, D, F)

• Propionic acidemia (PROP)

Other Disorders

• Biotinidase deficiency (BIOT)

• Galactosemia (GALT)

• Cystic fibrosis (CF)

• Severe combined immunodeficiency (SCID)_

2nd Screen: Performed 10–14 days of age -

Amino Acid Disorders

• Argininemia (ARG)

• Argininosuccinic aciduria (ASA)

• Citrullinemia, type I (CIT)

• Citrullinemia, type II (CIT II)

• Phenylketonuria (PKU)

• Homocystinuria (HCY)

• Hypermethioninemia (MET)

• Maple syrup urine disease (MSUD)

• Tyrosinemia, type I (TYR I)

• Tyrosinemia, type II (TYR II)

Endocrine Disorders

• Congenital adrenal hyperplasia (CAH)

• Primary congenital hypothyroidism (CH)

Fatty Acid Oxidation Disorders

• Carnitine acylcarnitine translocase deficiency (CACT)

• Carnitine palmitoyltransferase I deficiency (CPT-IA)

• Carnitine palmitoyltransferase type II deficiency (CPT-II)

• Carnitine uptake defect (CUD)

• Glutaric acidemia, type II (GA-2)

• Long-chain L-3 hydroxyacyl-CoA dehydrogenase deficiency (LCHAD)

• Medium-chain acyl-CoA dehydrogenase deficiency (MCAD)

• Short-chain acyl-CoA dehydrogenase deficiency (SCAD)

• Trifunctional protein deficiency (TFP)

• Very long-chain acyl-CoA dehydrogenase deficiency (VLCAD)

Organic Acid Conditions

• 2-Methyl-3-hydroxybutyric acidemia (2M3HBA)

• 2-Methylbutyrylglycinuria (2MBG)

• 3-Hydroxy-3-methylglutaric aciduria (HMG)

• 3-Methylcrotonyl-CoA carboxylase deficiency (3-MCC)

• 3-Methylglutaconic aciduria (3MGA)

• Beta-ketothiolase deficiency (BKT)

• Glutaric acidemia type I (GA1)

• Holocarboxylase synthetase deficiency (MCD)

• Isobutyrylglycinuria (IBG)

• Isovaleric acidemia (IVA)

• Malonic acidemia (MAL)

• Methylmalonic acidemia (cobalamin disorders) (Cbl A,B)

• Methylmalonic acidemia (methymalonyl-CoA mutase deficiency) (MUT)

• Methylmalonic acidemia with homocystinuria (Cbl C, D, F)

• Propionic acidemia (PROP)

Other Disorders

• Biotinidase deficiency (BIOT)

• Galactosemia (GALT)

5.1.3.2. The Contractor or their subcontractor shall perform laboratory testing for the specimens that BDAACH mailed to contractor or subcontractor’s testing site via courier service and report patient results in a timely manner, but not more than 14 days from the receipt of specimen.

5.1.3.2.1. For the Contractor located in Korea, 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 be coordinate with Shipping Section for delivery schedule. 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.

5.1.3.3. The Contractor or their subcontractor shall provide all materials required for testing.

5.1.3.4. The Contractor or their subcontractor shall provide a Genetic Consultant who shall be available by phone and email for consultation for the follow-up, evaluation and long-term management of patients identified with disorders by this program.

5.1.3.5. The Contractor or their subcontractor shall ensure that the BDAACH laboratory is contacted within 1 hour for all samples that are placed on HOLD or REJECTED for testing.

5.1.3.6. The Contractor or their subcontractor shall ensure that all samples that are placed on HOLD or REJECTED are retained and stored for a minimum of 7 days from the notification date.

5.1.3.7. The Contractor or their subcontractor shall ensure that genetic counseling for healthcare providers for the interpretation of results that fall within both normal and abnormal range is available through telephonic support 24 hours a day, 7 days a week at no additional cost. Genetic counseling shall include the following:

5.1.3.7.1. Assist Department of Pathology staff with obtaining test results, modifying test requests, and obtaining information regarding tests and test services and resolving test related problems.

5.1.3.7.2. Assistance with difficulties associated with secure internet reporting.

5.1.3.7.3. Providing hard copy of test results from all tests performed in house, at separate locations within the Contractor’s organization, and by all tests performed by a subcontractor.

5.1.3.7.4. Provide consultation for the follow-up, evaluation and long-term management of patients identified with disorders by this program.

5.1.3.7.5. The Contractor or their subcontractor shall call life threatening abnormal results within 1 hour directly to the Shipping/Receiving Section at 011- 82- 0503-337-7452. Notifications of unsatisfactory results and results indicating non-life threatening conditions are mailed to the Laboratory. A letter which indicates recommended follow-up shall be attached to the computerized result form. An additional Newborn Screen test form shall be provided when the repeat testing is recommended. This form shall be coded to link it to the primary specimen results and identify the repeat specimen as follow-up.

5.1.3.8. All other turnaround times shall be IAW its published Turn Around Time schedules in the reference lab’s Lab Manual in compliance with the current standards published in the College of American Pathologists, Lab Accreditation Standards, Lab General Checklist and shall be compliant with the Health Insurance Portability and Accountability Act (HIPAA) regulations. The Contractor and their subcontractor shall not release patient's test results, without the specific written consent to release such information as provided by the patient, to any person other than the ordering healthcare provider or designated.

5.1.3.9. The Contractor or their subcontractor shall ensure that ALL test results are available via their secured web-based application within the minimum turn-around time allotted.

5.1.3.10. The Contractor or their subcontractor shall ensure that ABNORMAL and CRITICAL test results are provided via telephone and facsimile to the ordering physician at the telephone number listed on the test requisition form and to laboratory personnel at no additional cost.

5.2. Requirements for all positions.

5.2.1. The Contractor or their subcontractor 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.

5.2.2. The contract or their subcontractor 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.

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

5.2.4 Continuing Education. The Contractor or their subcontractor 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 or their subcontractor 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.

5.3. 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 Contracting Officer KPP Key Performance Parameter MAC Multiple Award Contract MHS Military Health System MTF Military or Medical Treatment Facility NACI National Agency Check with Written Inquiries NAICS North American Industry Classification System NoPP Notice of Privacy Practices PHI Protected Health Information PII Personally Identifiable Information PKO Procuring Contracting Officer PMO Program Management Office PRS Performance Requirements Summary PSC Product Service Code PWS Performance Work Statement QA Quality Assurance QASP Quality Assurance Surveillance Plan QCP Quality Control Plan WAWF Wide Area Work Flow

END OF PERFORMANCE WORK STATEMENT

(End of Summary of Changes)