W9114F22Q0001 Amendment 0001.pdf

W40M RHCO USAHCA EUROPE

REGIONAL HEALTH CONTR OFC EUROPE

POC: HENNING MAYER-GOLDSTEIN

CMR 402

APO AE 09180

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

See Page 2 for the purpose of this amendment.

1. CONTRACT ID CODE PAGE OF PAGES

J 1 32

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

16C. DATE SIGNED

BY 29-Mar-2022

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 W9114F22Q0001

X 9B. DATED (SEE ITEM 11)

08-Mar-2022

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

29-Mar-2022

CODE

W40M RHCO USAHCA EUROPE

REGIONAL HEALTH CONTR OFC EUROPE

CMR 402

APO AE 09180

W9114F 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE W9114F

FACILITY CODECODE

EMAIL:TEL:

W9114F22Q0001

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 1449 - CONTINUATION SHEET

The following have been added by full text:

PURPOSE OF AMENDMENT 0001

The purpose of amendment 0001 it to provide answers to questions received from industry, which requires adjustment of the following:

Performance Work Statement (PWS)

a. Revise PWS Paragraph 1.4.4.

b. Revise PWS Paragraph 1.5.1.1.

c. Revise PWS Paragraph 1.5.2.1.

d. Revise PWS Paragraph 1.6.1.5.

e. Revise PWS Paragraph 5.2.2.1.

f. Revise "Monthly COR Report" with "Monthly Report" and "Quarterly Regional Report" & "Quarterly Summary Report" with "Quarterly Report" in PWS Paragraphs 5.7.1., 5.7.2. and 5.7.2.3.

g. Revise PWS Paragraph 5.9.1.

Technical Exhibit B, Performance Requirement Summary (PRS)

h. Revise PRS Statements 5.6. a) & b)

Addendum to 52.212-1 Instructions to Offerors

i. Added Paragraph 52.212-1 (o)

Exhibit A – Schedule of Required Tests

j. Revised on 11 March 2022.

See 'Summary of Changes' for details.

(End of Purpose of Amendment 0001)

QUESTIONS & ANSWERS

Question 1: Which destinations are in plan? This is important for organizing pick-up services if not from Landstuhl.

Reference 1: Page 9 of 82, Clause 52.216-22 INDEFINITE QUANTITY. (OCT 1995), Paragraph (c) … “The Government may issue orders requiring delivery to multiple destinations or performance at multiple locations.”

Answer 1: Only the Landstuhl Regional Medical Center will be supported with the resultant contract.

Question 2: How does the certification / compliance plan for prohibited activities apply to our company?

Reference 2: Page 15 of 82, Clause 52.222-50 COMBATING TRAFFICKING IN PERSONS (NOV 2021)

ALTERNATE I (MAR 2015),

“... (3) Minimum requirements ... (4)(ii) The Contractor shall provide the compliance plan to the Contracting Officer upon request.

(5) Certification. Annually after receiving an award, the Contractor shall submit a certification to the Contracting Officer that—

(i) It has implemented a compliance plan to prevent any prohibited activities ...”

Answer 2: U.S. Government is combatting trafficking in persons to the maximum extent possible. Federal Acquisition Regulation (FAR) paragraph 22.1705(a)(1) requires to insert the clause at 52.222-50, Combating Trafficking in Persons, in all solicitations and contracts. Its Alternate 1 is specifically applicable to contracts outside the continental United States.

Question 3: What exactly is requested from the Contractor in regards to National Institute of Standards and Technology (NIST) Special Publication (SP) 800-171?

Reference 3: Page 20 of 82, Clause 252.204-7012 SAFEGUARDING COVERED DEFENSE INFORMATION

AND CYBER INCIDENT REPORTING (DEC 2019),

“(i) Except as provided in paragraph (b)(2)(ii) of this clause, the covered contractor information system shall be subject to the security requirements in National Institute of Standards and Technology (NIST) Special Publication (SP) 800-171, “Protecting Controlled Unclassified Information in Nonfederal Information Systems and Organizations” (available via the internet at http://dx.doi.org/10.6028/NIST.SP.800-171) in effect at the time the solicitation is issued or as authorized by the Contracting Officer.”

Answer 3: Defense Federal Acquisition Regulation Supplement (DFARS) Paragraph 204.7304(c) requires to insert the clause at 252.204-7012, Safeguarding Covered Defense Information and Cyber Incident Reporting, in all solicitations and contracts, including solicitations and contracts using FAR part 12 procedures for the acquisition of commercial items, except for solicitations and contracts solely for the acquisition of commercially available off-the-shelf (COTS) items. Contractor compliance with National Institute of Standards and Technology (NIST) Special Publication (SP) 800-171 is required because processing of healthcare data is required during the performance of the resultant contract.

Question 4: How does the "Transportation of Supplies by Sea" apply to the Contractor?

Reference 4: Page 28-31 of 82, Clause 252.247-7023 TRANSPORTATION OF SUPPLIES BY SEA (FEB 2019)

Answer 4: Defense Federal Acquisition Regulation Supplement (DFARS) Paragraph 247.574(b) requires inserting the clause at 252.247-7023, Transportation of Supplies by Sea, in all solicitations and contracts, including solicitations and contracts using FAR part 12 procedures for the acquisition of commercial items, except those for direct purchase of ocean transportation services. However, no transportation of supplies by sea is required during the performance of the resultant contract.

Question 5: Our Company can ensure the requested qualifications for its own or affiliates' personnel.

Reference 5: Page 34 of 82, PWS Paragraph 1.4.4., “1.4.4. The Contractor shall ensure all testing and supervisory personnel at all contractor-owned, affiliate, or subcontracted laboratories assigned to work under this contract meet and maintain the applicable personnel qualifications set forth under the Clinical Laboratory Improvement Amendments (CLIA) of 1988 regulations.”

Answer 5: PWS Paragraph 1.4.4. was found to be too restrictive and was therefore revised to state the following:

1.4.4. The Contractor shall ensure all testing and supervisory assigned to work under this contract meet and maintain the applicable personnel qualifications set forth under the Clinical Laboratory Improvement Amendments (CLIA) of 1988 regulations. The Contractor shall evaluate contractor-owned, affiliated, or subcontracted laboratories working under the contract to ensure appropriate regulatory requirements are in place and followed.

http://dx.doi.org/10.6028/NIST.SP.800-171

Question 6: Our Company’s representatives are available on regular working hours.

Reference 6: Page 35 of 82, PWS Paragraph 1.5.1.1., “1.5.1.1. The Contractor Representative must be available telephonically, or in person by appointment, as needed, for troubleshooting, servicing, introducing new tests, to discuss immediate administrative, technical issues, or problem areas the customers may be experiencing in the field, etc. During non-duty hours, the Contractor Representative shall be accessible by cell phone or pager.”

Answer 6: PWS Paragraph 1.5.1.1. was found to be too restrictive and was therefore revised to state the following:

1.5.1.1. The Contractor Representative must be available telephonically, or in person by appointment, as needed during the Contractors published business hours, for troubleshooting, servicing, introducing new tests, to discuss immediate administrative, technical issues, or problem areas the customers may be experiencing in the field, etc.

Question 7: Testing is routinely provided 5 days a week from Monday through Friday on regular duty hours.

Testing services on Saturdays is provided on rare occasions and for few routine tests only, e.g. Corona/COVID-19.

Reference 7: Page 35 of 82, PWS Paragraph 1.5.2.1., 6 days testing, “1.5.2.1. The Contractor shall provide testing service 6 days a week.”

Answer 7: PWS Paragraph 1.5.2.1. was found to be too restrictive and was therefore revised to state the following:

1.5.2.1. The Contractor shall provide testing service 5 days a week.

Question 8: All of our company's in-house tests are validated and CAP accredited but are not necessarily FDA approved. Our testing platforms are CE approved.

Reference 8: Page 36 of 82, PWS Paragraph 1.6.1.4. FDA, “Any non-FDA approved method being performed shall have a documented validation plan. Upon request, the validation plan and validation results shall be made available to the COR or designee. All instrumentation, testing methods, and standard operating procedures shall be validated prior to implementation and use by the Contractor providing blood donor testing in accordance with FDA requirements.”

Answer 8: PWS Paragraph 1.6.1.4. does not require all tests to be FDA approved. Any non-FDA methods should be validated appropriately and documentation should be available if requested.

Question 9: Our Company has no formal subcontracts in place but buys services from our German reference labs who are DaKKs (Deutsche Akkreditierungsstelle) accredited but not CAP accredited.

Reference 9: Page 36 of 82, PWS Paragraph 1.6.1.5. subcontracted laboratories, “1.6.1.5. The Contractor shall ensure that subcontracted laboratories comply with and meet all accreditations/certifications as the prime Contractor.”

Answer 9: PWS Paragraph 1.6.1.5. was found to be too restrictive and was therefore revised to state the following:

1.6.1.5. The Contractor shall ensure that subcontracted laboratories comply with and meet all accreditations/certifications as the prime Contractor or their European equivalent.

Question 10: How does this apply to foreign companies?

Reference 10: Page 36 of 82, PWS Paragraph 1.8.2. and following, Information Security, HIPAA, “1.8.2. Information Security. Electronic transmission of identifiable patient information shall be in compliance with requirements of the Privacy Act and Health Insurance Portability and Accountability Act (HIPAA). The following security requirements are in addition to the DoD, U.S. Army, or other Government agency basic policy of initial and periodic security training, and the need for physical controls to protect hardware. ...”

Answer 10: The security requirements captured in subheadings 1.8.2.1 through 1.8.2.3 apply. This requirement addresses the sensitivity of patient test results. For more information on US Privacy Act and HIPAA, visit https://www.enisa.europa.eu/topics/threat-risk-management/risk-management/current-risk/laws-regulation/data-protection-privacy/health-insurance-portability-and-accountability-act.

Question 11: All of our company's in-house tests are validated and CAP accredited but are not necessarily FDA approved. Our testing platforms are CE approved.

Reference 11: Page 40 of 82, PWS Paragraph 5.1.2. Testing (FDA), “5.1.2. TESTING. The Contractor shall be CAP accredited and provide testing on a platform approved by the FDA.

Any non-FDA approved method being performed shall have a documented validation plan. Upon request, the validation plan and validation results shall be made available to the COR or designee. All instrumentation, testing methods, and standard operating procedures shall be validated prior to implementation and use by the Contractor providing blood donor testing in accordance with FDA requirements. …”

Answer 11: PWS Paragraph 5.1.2. does not require all tests to be FDA approved. Any non-FDA methods should be validated appropriately and documentation should be available if requested.

Question 12: Our Company’s test results are electronically transmitted upon the TAT per test given on our daily updated website test list. Tests not found on this online test list can be inquired on demand.

Reference 12: Page 42 of 82, PWS Paragraph 5.2.2.1. results reporting, “Test results reporting. Routine test results shall be electronically uploaded to a shared file system or emailed to DPALS within 72 hours of specimen receipt.”

Answer 12: PWS Paragraph 5.2.2.1. was found to be too restrictive and was therefore revised to state the following:

5.2.2.1. Test results reporting. Routine test results shall be electronically uploaded to a shared file system or emailed to DPALS within the Contractor’s published turnaround time.

Question 13: To be determined in more details.

Reference 13: Page 42 of 82, PWS Paragraph 5.5. referrals to another lab, “5.5. REFERRALS TO ANOTHER LABORATORY OR INSTITUTION. The Contractor shall ship specimens to other laboratories as required when referral work is sent by the Government to another institution which may be conducting joint studies or when the specimen is time sensitive. Specimen transport expense for referrals to another laboratory or institution are at no additional cost to the Government.”

Answer 13: If the Contractor must send a test to another lab for additional work, transport costs remain with the Contractor.

Question 14: To be determined in more details. What is the difference between monthly and quarterly report as well as COR reports and quarterly regional reports?

https://www.enisa.europa.eu/topics/threat-risk-management/risk-management/current-risk/laws-regulation/data-protection-privacy/health-insurance-portability-and-accountability-act https://www.enisa.europa.eu/topics/threat-risk-management/risk-management/current-risk/laws-regulation/data-protection-privacy/health-insurance-portability-and-accountability-act

Reference 14: Page 43 of 82, PWS Paragraph 5.7. Management Reports, “5.7. MANAGEMENT REPORTS.

5.7.1. Monthly COR Reports. The Contractor shall provide separate monthly data summary reports of tests performed to the COR. The printed reports shall be delivered to the contracting officer and to the COR as identified on the contract, by the tenth calendar day of the month after the end of each monthly reporting period. …

5.7.2. Quarterly Regional Reports. The Contractor shall provide quarterly data summary reports of tests performed to the COR. The printed reports shall be delivered to the COR, and contracting officer no later than the tenth calendar day of the month after the end of each quarter. Letter issued to the Contractor after award of the contract will identify the COR. …

5.7.2.3. The Contractor shall provide the COR and contracting officer a Quarterly Summary Report. …”

Answer 14: The requirements for the Monthly and Quarterly reports are detailed in the subheadings of PWS Paragraph 5.7. The report descriptions were revised from "Monthly COR Report" to "Monthly Report" as well as "Quarterly Regional Report" and "Quarterly Summary Report" to "Quarterly Report" in PWS Paragraphs 5.7.1.,

5.7.2. and 5.7.2.3.

Question 15: Does not apply to our company because our company does not provide any blood donor testing services. We must clearly point out that we do neither perform nor arrange any blood donation testing. Our scope of services consists of clinical chemistry, toxicology (e.g. drug monitoring) hematology / oncology, infectious diseases, endocrinology, immunology / serology as well as human genetics and molecular pathology.

Reference 15: Page 44 of 82, PWS Paragraph 5.9.1. State donor center, “5.9.1. The Government COR’s will brief the Contractor as to where to ship their shipping/packaging materials. If needed, the Contractor can make a site visit to State donor center to instruct personnel on labeling, packing and shipping requirements.”

Answer 15: PWS Paragraph 5.9.1. applies. The visiting site has been changed from our donor center to the laboratory.

PWS Paragraph 5.9.1. was revised to state the following:

5.9.1. The Government COR’s will brief the Contractor as to where to ship their shipping/packaging materials. If needed, the Contractor can make a site visit to DPALS to instruct personnel on labeling, packing and shipping requirements.

Question 16: What is this and how does DoD AI-15 apply to foreign companies?

Reference 16: Page 46 of 82, Technical Exhibit A, Personally Identifiable Information, Protected Health Information, and Federal Information Requirements, Records Management, “2. Records Management When creating and maintaining official government records, the Contractor shall comply with all federal requirements established by 44 United States Code (U.S.C.) Chapters 21, 29, 31, 33 and 35, and by 36 CFR, Chapter XII, Subchapter B – Records Management. The Contractor shall also comply with DoD Administrative Instruction No. 15 (DoD AI-15), “OSD Records and Information Management Program” (May 3, 2013) and Records Management requirements outlined in the current TRICARE Operations Manual (TOM).”

Answer 16: All regulations, policies and instructions referred to in Technical Exhibit A apply and are to be followed due to the sensitivity of Patient Information. DoD AI-15 is applicable to all Department of Defense (DoD) Components and to whom provides records management support. DoD AI-15 is available at https://www.esd.whs.mil/Directives/issuances/admin_inst/

Question 17: As a German company, our company is not subject to PIA, as we must comply with the European Data Protection Regulation entitled General Data Protection Regulation (GDPR) and German law.

https://www.esd.whs.mil/Directives/issuances/admin_inst/

Reference 17: Page 47 of 82, Technical Exhibit A, Personally Identifiable Information, Protected Health Information, and Federal Information Requirements, PIA, “5. Privacy Impact Assessment (PIA) If DHA data is stored on a Contractor owned system, a PIA is required from the Contractor.”

Answer 17: All regulations, policies and instructions referred to in Technical Exhibit A apply and are to be followed due to the sensitivity of Patient Information. Privacy Impact Assessment (PIA) information is available at https://www.health.mil/Military-Health-Topics/Privacy-and-Civil-Liberties/Privacy-Impact-Assessments. Privacy Impact Assessment Desk Reference Guide is available at https://www.health.mil/Reference- Center/Forms/2016/03/21/DHA-PIA-Guide

Question 18: As a German Company this does not apply to us, as we must comply with the European Data Protection Regulation entitled General Data Protection Regulation (GDPR) and German law.

Reference 18: Page 48 of 82, Technical Exhibit A, Personally Identifiable Information, Protected Health Information, and Federal Information Requirements, “7. Privacy Act and HIPAA Training The Contractor shall ensure that its entire staff, including subcontractors and consultants that perform work on this Contract receive training on the Privacy Act, HIPAA, and the federal regulations on confidentiality of substance use disorder patient records, 42 CFR Part 2. Refer to FAR 52.224-3 regarding specific requirements for Privacy Training appropriate to the Contractor’s scope of involvement with DHA’s PHI and its regulatory responsibilities as either a Covered Entity, or Business Associate.

The Contractor shall ensure all employees and subcontractors supply a certificate of all training completion to the Contracting Officer’s Representative (COR) within 30 days of being assigned and on an annual basis based on the trainee’s birth month thereafter.”

Answer 18: All regulations, policies and instructions referred to in Technical Exhibit A apply and are to be followed due to the sensitivity of Patient Information. Training requirements also apply as described in the referenced paragraph.

Question 19: Tests results are provided upon depending TAT as per test list. Our company’s test results are electronically transmitted upon the TAT per test given on our daily updated website test list. Tests not found on this online test list can be inquired on demand.

Reference 19: Page 53 of 82, Technical Exhibit B, Performance Requirement Summary (PRS), Statement 5.6.

Generate and provide test results.

“Statement 5.6. Generate and provide test results.

a) Generate and provide Standard Panel Test Results within 72 hours after receipt of specimens AQL: On 95% of the submitted specimens within a month

b) Generate and provide Confirmatory Testing Results within 72 hours after receipt of specimens if applicable AQL: On 95% of the submitted specimens within a month

c) Release abnormal results to DPALS immediately AQL: On 100% of abnormal results”

Answer 19: PRS Statements 5.6. a) & b) were found to be too restrictive and was therefore revised to state the following:

a) Generate and provide Standard Panel Test Results within the Contractor’s published turnaround time AQL: On 95% of the submitted specimens within a month

b) Generate and provide Confirmatory Testing Results within the Contractor’s published turnaround time AQL: On 95% of the submitted specimens within a month https://www.health.mil/Military-Health-Topics/Privacy-and-Civil-Liberties/Privacy-Impact-Assessments https://www.health.mil/Reference-Center/Forms/2016/03/21/DHA-PIA-Guide https://www.health.mil/Reference-Center/Forms/2016/03/21/DHA-PIA-Guide

Question 20: To be determined in more details. What is the difference between monthly and quarterly report as well as COR reports and quarterly regional reports?

Reference 20: Page 53 of 82, Technical Exhibit B, Performance Requirement Summary (PRS), Statement 5.7.

Generate and provide management reports.

“5.7. Generate and provide management reports.

a) Generate and provide Monthly Reports by the 10th calendar day of the following month AQL: On 100% of the submitted specimens within the reporting period

b) Generate and provide Quarterly Reports by the 10th calendar day of the following month AQL: On 100% of the submitted specimens within the reporting period”

Answer 20: Management Reports (Monthly/Quarterly) and their differences were described in detail in PWS Paragraph 5.7.

(End of Questions & Answers)

The following have been modified:

PERFORMANCE WORK STATEMENT

PERFORMANCE WORK STATEMENT

FOR

DEPARTMENT OF PATHOLOGY AND

AREA LABORATORY SERVICES (DPALS)

TABLE OF CONTENTS

SECTION TITLE

C-1 General Information 1 – 3 C-2 Definitions C-3 Government Responsibilities C-4 Contractor Responsibilities C-5 Description of work C-6 Applicable Regulations, Manuals, Technical Documents, Specifications, and Forms C-7 Sexual Harassment/Assault Response and Prevention (SHARP) Program

Technical Exhibits - Summary

Technical Exhibit A: Personally Identifiable Information, Protected Health Information, and Federal

Information Requirements Technical Exhibit B: Performance Requirement Summary (PRS) for Standard Reference Testing.

SECTION C-1 GENERAL INFORMATION:

1. GENERAL. This is a non-personal services contract to provide Reference Laboratory testing for the Department of Pathology and Area Laboratory Services (DPALS) at Landstuhl Regional Medical Center (LRMC). The Government will not exercise any supervision or control over the Contractor employees performing services herein.

Such employees shall be accountable solely to the Contractor who, in turn, is responsible to the Government.

1.1. SCOPE. The Contractor shall provide all required facilities, personnel, services, materials, equipment, and supplies required to meet the requirements outlined in this Performance Work Statement. All testing shall be in accordance with the College of American Pathologists (CAP) standards for laboratory performance.

1.1.1. The Contractor shall maintain College of American Pathologists (CAP) accreditation throughout the entire period of the Contract.

1.2. REQUIREMENTS. The Contactor shall provide, at a minimum, testing capabilities for the tests listed in PWS paragraph 5., entitled “Description of Work”. The Contractor shall provide any confirmatory testing and additional tests required per CAP guidance. All laboratory testing shall be executed in accordance with standard industry practices. All tests shall be executed at the Contractor's premises, or within the Contractor's network of laboratories (affiliate or qualified subcontractor).

1.3. NON-PERSONAL SERVICES. The Government shall neither supervise Contractor employees nor control the method by which the Contractor performs the required tasks. Under no circumstances shall the Government assign tasks to, or prepare work schedules for, individual Contractor employees. It shall be the responsibility of the Contractor to manage its employees and to guard against any actions that are of the nature of personal services, or give the perception of personal services. If the Contractor believes that any actions constitute, or are perceived to constitute personal services, it shall be the Contractor's responsibility to notify the Procuring Contracting Officer (PCO) immediately.

1.4. CONTRACTOR RESPONSIBILITY.

1.4.1. The Contractor shall ensure all employees under this contract who will be interacting with Government personnel (i.e., contractor representative, customer service personnel, data entry/specimen processing technician, and courier) are able to read, write, and speak English fluently, with sufficient clarity, to effectively communicate.

1.4.2. The Contractor shall ensure each laboratory possesses all legally-required license(s), certification(s), and accreditation(s) in accordance with Federal statutes and implementing regulations as well as those of the State in which the laboratory is located. The Contractor shall ensure any subcontractors performing services hereunder shall meet the same requirements as the prime Contractor. Proof of the above required certification(s), accreditation(s), license(s), etc., shall be provided to DPALS.

1.4.3. The Contractor shall ensure its employees have the ability to perform the applicable duties consistent with their license and certification. The Contractor shall ensure all laboratory testing staff complies with CAP regulations/standards regarding their certification or registry.

1.4.4. The Contractor shall ensure all testing and supervisory assigned to work under this contract meet and maintain the applicable personnel qualifications set forth under the Clinical Laboratory Improvement Amendments (CLIA) of 1988 regulations. The Contractor shall evaluate contractor-owned, affiliated, or subcontracted laboratories working under the contract to ensure appropriate regulatory requirements are in place and followed.

1.4.5. The Contractor shall submit a copy of the professional certification and/or licensure of the corporate Laboratory Director and/or Medical Director to the Contracting officer’s Representative (COR) within 10 working days after contract award. The Contractor shall also submit copies of all certifications/licenses for the Technical Supervisors of the Primary Contractor’s laboratory.

1.5. CONTRACTOR PERSONNEL.

1.5.1. Contractor Representative. The Contractor shall designate and submit, in writing, within 10 working days after award, the name of a full-time Contractor representative and alternate. The written designation shall be submitted to the contracting officer and the COR as identified on the contract. The Contractor shall also provide the telephone, pager, cell phone and facsimile numbers and email address for the designated full-time Contractor representative and alternate.

1.5.1.1. The Contractor Representative must be available telephonically, or in person by appointment, as needed during the Contractors published business hours, for troubleshooting, servicing, introducing new tests, to discuss immediate administrative, technical issues, or problem areas the customers may be experiencing in the field, etc.

1.5.2. Customer Services. The Contractor shall provide customer service which shall be accessible telephone service to assist Government staff in tracking test results, modifying test requests, obtaining information regarding specimen requirements, and other applicable related issues/problems that may arise in the performance of work under this contract.

1.5.2.1. The Contractor shall provide testing service 5 days a week.

1.5.2.2. The Contractor shall provide all necessary instructions for shipping and supplies for biologic specimens to be transported from DPALS to the Contractor.

1.5.2.3. The primary result reporting shall be by email or shared electronic file to the representatives of DPALS.

Results shall be e-mailed or uploaded upon completion of the testing and verification of results for accuracy within a 72 hours period of specimen receipt. The Contractor shall issue advanced notice to the COR of any anticipated testing/result delays via e-mail. Unexpected testing/result delays shall be communicated immediately to the COR via telephone and email.

1.5.2.3.1. A list of email addresses will be provided by DPALS within 10 working days after award to the Contractor to provide results electronically.

1.5.2.4. The Contractor shall bring any errors or discrepancies to the attention of the representatives of DPALS immediately upon discovery.

1.6. PERFORMANCE QUALITY.

1.6.1. CONTRACTOR QUALITY CONTROL (QC) PLAN. The Contractor shall provide a copy of its existing Quality Control Plan within 10 working days after award of the contract. Any changes made after award of contract shall be submitted to the COR and to the Contracting Officer for Government’s review and approval prior to implementation.

1.6.1.1. A progress meeting shall be held by telephone within 60 calendar days after contract start date between the COR and the Contractor to discuss any issues.

1.6.1.2. The Contractor shall perform external proficiency testing surveys as required by CLIA for all regulated analytes. The Contractor shall provide the COR a listing of external proficiency surveys that the laboratory participates in accordance with CLIA. Survey results and statistical reviews for specific laboratory specialties shall be provided to COR or designee upon request.

1.6.1.3. The Contractor shall operate a quality control program; current CLIA requirements are located at the Centers for Disease Control and Prevention (CDC) website: https://www.cdc.gov/clia/. Upon request of the COR , the Contractor shall provide documentation of quality assurance policies, quality control results for assays, on-going calculations of quality control performance (coefficient of variation, mean and standard deviation), monthly Levy- Jennings graphs, and documentation of appropriate analyzer maintenance. Upon request, the Contractor shall provide verification results for assays of non-regulated analytes, and analytes for which proficiency testing does not currently exist.

1.6.1.4. Any non-FDA approved method being performed shall have a documented validation plan. Upon request, the validation plan and validation results shall be made available to the COR or designee. All instrumentation, testing methods, and standard operating procedures shall be validated prior to implementation and use by the Contractor providing blood donor testing in accordance with FDA requirements.

https://www.cdc.gov/clia/

1.6.1.5. The Contractor shall ensure that subcontracted laboratories comply with and meet all accreditations/certifications as the prime Contractor or their European equivalent.

1.6.2. Government Performance Requirements Summary (PRS). The Government will monitor the Contractor’s performance under this contract, in part using specimen pick times, result turn-around times, percentage of discrepant results and by selected inspections or audits of the Contractor’s own written instructions and procedures.

1.6.3. The Contractor shall notify the Contracting Officer immediately, in writing, upon its loss of any required certification, accreditation, or licensure.

1.7. SAFETY REQUIREMENTS. The Contractor shall:

1.7.1. Maintain safety and health standards consistent with the requirements set forth by the Occupational, Health, and Safety Administration (OSHA), and the Center for Disease Control (CDC) and Prevention.

1.8. SECURITY REQUIREMENTS.

1.8.1. Physical Security.

1.8.1.1. 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.

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 7 calendar days after completion of training by all employees and subcontractor personnel. AT level I awareness training is available at the following website: https://jko.jten.mil/

1.8.1.2. The Contractor shall obtain all local, State and Federal Government licenses, passes and permits necessary to enter the Government installation to include motor vehicle registration and insurance as required.

1.8.2. Information Security. Electronic transmission of identifiable patient information shall be in compliance with requirements of the Privacy Act and Health Insurance Portability and Accountability Act (HIPAA). The following security requirements are in addition to the DoD, U.S. Army, or other Government agency basic policy of initial and periodic security training, and the need for physical controls to protect hardware.

1.8.2.1. Neither the Contractor, nor any of its employees, shall disclose or cause to be disseminated any information concerning military activity operations.

1.8.2.2. Neither the Contractor, nor any of its employees, shall disclose private medical information concerning patients to third parties other than those personnel designated by the Government at each Submitting Activity to receive patient results. Results shall be handled as private medical records in accordance with Army Regulation 40- 66, North Atlantic Treaty Organization Standardization Agreements 2348 ED.3(1) , and 2132 ED.2 and American- British-Canadian-Australian Quadripartite Standardization Agreement 470 ED.1.

1.8.2.3. All inquiries, comments or complaints pertaining to patient information or Government information, arising from any matter observed, experienced, or discovered as a result of, or in connection with, the performance of this contract shall be directed to the COR for resolution.

SECTION C-2 DEFINITIONS

2. DEFINITIONS/ACRONYMS:

2.1. DEFINITIONS. Following is a list of basic definitions.

https://jko.jten.mil/

2.1.1. CONTRACT ADMINISTRATOR. The official Government representative delegated authority by the Contracting Officer to administer a contract. This individual is normally a member of the appropriate Contracting/Procurement career field and advises on all technical contractual matters.

2.1.2. CONTRACTOR. The term as used in this contract refers to both the prime and subcontractors.

2.1.3. CONTRACTING OFFICER: A person with the authority to enter into, administer and/or terminate contracts and make related determinations and findings. Note: The only individual who can legally bind the Government.

2.1.4. CONTRACTING OFFICER'S REPRESENTATIVE (COR): An employee of the U.S. Government appointed by the Contracting Officer to administer the contract. Such appointment shall be in writing and shall state the scope of authority and limitations. This individual has authority to provide technical direction to the Contractor as long as that direction is within the scope of the contract, does not constitute a change, and has no funding implications. This individual does NOT have authority to change the terms and conditions of the contract.

2.1.5. SECURITY REQUIREMENTS. These are found in the National Security Agency “Orange Book” (DoD 5200.28-STD, DoD Trusted Computer System Evaluation Criteria). Basically, computer system processing is sensitive, but unclassified information, and shall have the appropriate security features. The following security requirements are in addition to the U.S. Army’s basic policy of initial and periodic security training and the need for physical controls to protect hardware. For example:

Discretionary Access Control; (access control lists).

Object Reuse; (hard drives/diskettes shall be wiped clean of information before turned in to supply for transfer back to the Contractor).

Identification and Authentication (user ID and passwords to use the system).

Audit (the system shall have audit trail capability).

Operational Assurance (protection from external interference or tampering).

Accreditation (signed by a designated accreditation authority).

2.1.6. DEFECTIVE SERVICE. A service output that does not meet the standard of performance associated with the Performance Work Statement.

2.1.7. GOVERNMENT-FURNISHED PROPERTY (GFP) OR GOVERNMENT PROPERTY (GP). Property in the possession of, or directly acquired by, the Government and subsequently made available to the Contractor.

2.1.8. KEY PERSONNEL. Contractor personnel that are evaluated in a source selection process and that may be required to be used in the performance of a contract by the Key Personnel listed in the PWS. When key personnel are used as an evaluation factor in best value procurement, an offer can be rejected if it does not have a firm commitment from the persons that are listed in the quote.

2.1.9. PHYSICAL SECURITY. Actions that prevent the loss or damage of Government property.

2.1.10. QUALITY ASSURANCE. The Government procedures to verify that services being performed by the Contractor are acceptable in accordance with established standards and requirements of this contract.

2.1.11. QUALITY ASSURANCE SPECIALIST. An official Government representative concerned with matters pertaining to the contract administration process and quality assurance/quality control. Acts as technical advisor to the Contracting Officer in these areas.

2.1.12. QUALITY ASSURANCE SURVEILLANCE PLAN (QASP). A Government-developed document used to determine if the Contractor's performance meets the performance standards contained in the contract. The QASP establishes procedures on how this assessment/inspection process will be conducted. It provides the detailed process for a continuous oversight process.

2.1.13. QUALITY CONTROL. All necessary measures taken by the Contractor to assure that the quality of an end product or service shall meet contract requirements.

2.1.14. QUALITY ASSURANCE PROGRAM (QAP). All necessary measures taken by the Government to assure that the quality of an end product or service shall meet contract requirements.

2.1.15. SPECIMEN. A quantity of human blood, serum, tissue, excreta, patient body fluid, or environmental specimen provided for test purposes.

2.1.16. SUBCONTRACTOR. One that enters into a subcontract and assumes some of the obligations of the primary Contractor.

2.1.17. SUBMITTING ACTIVITY. Any Government activity submitting specimens under this contract.

2.1.18. TRANSFER TUBE. Any tube used to collect, transport, transship, and store samples under terms of the

PWS.

2.2. ACRONYMS/ABBREVIATIONS. Following is a list of basic acronyms/abbreviations used in the contract.

ACOR - Alternate Contracting Officer’s Representative AQL - Acceptable Quality Level CAP - College of American Pathologists CDC - Centers for Disease Control and Prevention (CDC) CFR - Code of Federal Regulations CLIA - Clinical Laboratory Improvement Amendments of 1988 COR - Contracting Officer Representative DoD - Department of Defense DPALS - Department of Pathology and Area Laboratory Services FDA - United States Food and Drug Administration FSC - Federal Service Code HHS - U.S. Department of Health and Human Services HIPAA - Health Insurance Portability & Accountability Act OSHA - Occupational, Health, and Safety Administration OTSG - Office of the Surgeon General, U.S. Army PRS - Performance Requirements Summary PWS - Performance Work Statement QASP - Quality Assurance Surveillance Plan QA - Quality Assurance QC - Quality Control SHARP - Sexual Harassment/Assault Response & Prevention Program

SECTION C-3 GOVERNMENT RESPONSIBILITIES

3. GOVERNMENT-FURNISHED FACILITIES, EQUIPMENT, MATERIAL AND SERVICES:

3.1. The Government will:

3.1.1. Perform specimen collection.

3.1.2. Provide biologic specimens that have been collected and processed per the Contractor’s published pre-analytical requirements, and in accordance with standard quality procedures.

3.1.3. Label each sample with a unique unit number and provide the Contractor with test requests, lists, or work documents with required ordering information per the Contractor’s requirements.

3.2. GOVERNMENT-FURNISHED ITEMS.

3.2.1. Specimens for testing.

SECTION C-4 CONTRACTOR RESPONSIBILITIES

4. CONTRACTOR-FURNISHED ITEMS

4.1. COMMERCIAL CLIENT SERVICES MANUAL. The Contractor shall provide both a hard and electronic copy of its Client Services Manual to the COR at the start-up period. The manual must be written in English.

Examples of the information to be provided include the following:

Test-specific specimen collection and preservation requirements.

Test-specific method and interpretation.

Test-specific method reference ranges.

Test-specific method sensitivity, specificity, and interferences.

Test-specific schedule of performance and average turnaround time.

Result Code

4.1.1. Updated information on test methodology changes, (i.e. changes in normal ranges, methods, and reporting units, etc.). In the event of any methodology change, written information/instruction shall be provided to the contracting officer and COR within 15 calendar days prior to the Contractor implementing said change. This will allow time for changes in testing algorithms – if needed. Changes to procedures with less than 15 calendar days notice shall be made only with concurrence by the COR. The COR will notify the contracting officer in the event of noncompliance with this requirement.

4.2. PRODUCT INFORMATION. The Contractor shall provide product information on new test(s) offered by the Contractor. Updated information shall be provided to Contracting Officer and COR once test procedure validation is complete.

4.3. MATERIALS/CONSUMABLES.

4.3.1. The Contractor shall furnish materials, supplies, equipment, and reagents necessary to meet the requirements for the provision of services established by this contract. Materials, supplies, equipment, and reagents must be delivered to DPALS within 10 calendar days of the initial request.

4.3.2. The Contractor shall furnish electronic/hardcopy test request forms.

4.3.3. The Contractor shall furnish instructions on how to place the barcode labels on each specimen transfer tube as required by the Contractors' barcode reading requirements for its instrumentation.

4.3.4. The Contractor shall furnish written instructions to Government personnel for sample preparation, applying barcode labels, packing samples, preparing paperwork, and shipping or transport of containers.

4.3.5. CUSTOMER SERVICE. The Contractor Customer Service shall be accessible by telephone service to assist Government staff in tracking test results, modifying test requests, obtaining information regarding specimen requirements, and other related issues that may arise.

SECTION C-5 DESCRIPTION OF WORK

5. SPECIFIC TASKS

5.1. TRANSPORTATION. The Contractor shall provide specimen pick up (via Courier) from DPALS and transport to the testing location. The Contractor courier will abide to all transportation rules set by the local government laws. Specimens prepared at DPALS must depart from and arrive at Contractor facility for processing within the same day.

5.1.1. The Contractor shall provide at a minimum one specimen pick-up per day (Monday – Friday), between the hours of 0900 and 1700.

5.1.2. TESTING. The Contractor shall be CAP accredited and provide testing on a platform approved by the FDA.

Any non-FDA approved method being performed shall have a documented validation plan. Upon request, the validation plan and validation results shall be made available to the COR or designee. All instrumentation, testing methods, and standard operating procedures shall be validated prior to implementation and use by the Contractor providing blood donor testing in accordance with FDA requirements. Contractor shall inform the COR of any delays expected to increase the result turnaround time beyond 72 hours via telephone and e-mail. All laboratory testing shall be executed in accordance with standard industry practices.

5.1.2.1. The Contractor shall ensure the accurate and timely performance of laboratory testing services for biologic specimens provided by DPALS. The quality for all services rendered hereunder shall conform to the highest standards in the clinical pathology and clinical reference laboratory professions as established by accrediting and licensing agencies.

5.1.3. PATIENT TESTING.

5.1.3.1. Minimum standard testing capability of the servicing local reference laboratory.

5.1.3.2. Acetylcholinesterase

5.1.3.3. Galactose-1-Phosphate

5.1.3.4. Platelet abs, free / cellbound

5.1.3.5. Acid Phospatase, total

5.1.3.6. Galactose-1-Phosphate-Uridyltransferase (B)

5.1.3.7. PM/Scl abs

5.1.3.8. Ameobic IgG abs

5.1.3.9. Glucagon

5.1.3.10. Pneumococcal abs

5.1.3.11. Amphetamines confirmation (LC-MS/MS)

5.1.3.12. Glucose

5.1.3.13. Protein C & S activity

5.1.3.14. Anti Streptococcal Hyaluronidase (ASH)

5.1.3.15. Gold

5.1.3.16. Anti Thrombin (AT)

5.1.3.17. HAV RNA PCR (f)

5.1.3.18. Pseudomonas Aeruginosa IgG abs structure

5.1.3.19. Ascaris abs. (IgG)

5.1.3.20. HBV DNA quant

5.1.3.21. Pyruvate

5.1.3.22. Asialoglycoprotein receptor abs

5.1.3.23. HCV RNA QUANT

5.1.3.24. Quantiferon-TB Gold Plus Test

5.1.3.25. Basal membrane abs.

5.1.3.26. Heparin – Induced Thrombocytopenia screening

5.1.3.27. Quinidine

5.1.3.28. Biotin (Vitamin H)

5.1.3.29. HIV-1 RNA quantitative

5.1.3.30. Rabies abs

5.1.3.31. Biotinidase quant.

5.1.3.32. HLA

5.1.3.33. SARS-CoV-2 / SARS-Corona viruses

5.1.3.34. Ca-channel abs.

5.1.3.35. Human herpes virus abs.

5.1.3.36. Sirolimus

5.1.3.37. Caffeine

5.1.3.38. Interleukin 6

5.1.3.39. SMN1 gene, spinal muscular atrophy

5.1.3.40. Campylobacter jejuni abs

5.1.3.41. Ketamine

5.1.3.42. Sulfonylurea structure

5.1.3.43. Candida abs.

5.1.3.44. Lead

5.1.3.45. Thalassaemia / hemoglobinopathies

5.1.3.46. Carboxy hemoglobin

5.1.3.47. Lipoprotein electrophoresis

5.1.3.48. Tick borne encephalitis IgG and IgM

5.1.3.49. Chikungunya abs.

5.1.3.50. LSD

5.1.3.51. Ureaplasma parvum

5.1.3.52. Citrate

5.1.3.53. MAG abs

5.1.3.54. Ureaplasma urealyticum

5.1.3.55. Cryoglobulin qual.

5.1.3.56. Urine protein electrophoresis

5.1.3.57. Cystatin C

5.1.3.58. Methylphenidate

5.1.3.59. Urogenital Infections (PCR)

5.1.3.60. Cytomegalovirus abs. IgG

5.1.3.61. Varicella zoster virus abs

5.1.3.62. Cytomegalovirus abs. IgM

5.1.3.63. Mumps virus abs / IgG / IgA

5.1.3.64. VeriSeq Non Invasive Prenatal Test

5.1.3.65. DNA abs (single strand)

5.1.3.66. Mycoplasma genitalium PCR

5.1.3.67. VIP (vasoactive intestinal polypeptide)

5.1.3.68. Echinococcus abs

5.1.3.69. Mycoplasma hominis

5.1.3.70. VLDL cholesterol

5.1.3.71. Enterovirus abs.

5.1.3.72. Parvovirus

5.1.3.73. Xylose

5.1.3.74. G-6-PD (Glucose-6-Phospate Dehydrogenase)

5.1.3.75. Phenobarbital

5.1.3.76. Yellow fever

5.1.3.77. Standard tests not listed herein, but critical to the mission.

5.1.3.78. CONFIRMATORY TESTING. If confirmatory testing is necessary, the Contractor shall perform the additional confirmatory testing.

5.2. CONTRACTOR LABORATORY INFORMATION SYSTEM.

5.2.1. The Contractor shall provide and maintain a computerized laboratory information and management system for rapid retrieval and printing of laboratory results including elements within the Contractor’s laboratory. The Contractor shall maintain the test results in accordance with appropriate regulatory/accrediting agency guidelines.

5.2.2. The Contractor's automation shall provide:

5.2.2.1. Test results reporting. Routine test results shall be electronically uploaded to a shared file system or emailed to DPALS within the Contractor’s published turnaround time.

5.2.2.2. Any delays in testing due to failed runs, or instrument malfunctions should be reported immediately if delay in testing beyond 72 hours will occur.

5.2.2.3. Once…