Attachment 01 - Performance Work Statement_ 2026.01.12.pdf

Attachment 01

PERFORMANCE WORK STATEMENT

FOR

DEPARTMENT OF PATHOLOGY AND AREA LABORATORY SERVICES (DPALS)

SECTION 1 GENERAL INFORMATION:

1. GENERAL. This is a non-personal services contract to provide Local Laboratory Reference testing for Landstuhl Regional Medical Center (LRMC), Department of Pathology and Area Laboratory Services (DPALS). 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 identified in Attachment 04 - Schedule of Required Test. The Contractor shall provide any confirmatory testing and additional tests required per CAP guidance upon written approval. 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, 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.

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 College of American Pathologist (CAP). 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 provide a copy of the certificate of CAP accreditation within 15 working days after award, to the COR, for all Contractor-owned, affiliated, or subcontracted laboratories.

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

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

1.4.8. The primary result reporting shall be by email, shared electronic file or secure website 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.

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

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.

1.5.2. 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.

1.5.3. Customer Services Representative. The Contractor shall provide customer service representative 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.

1.6. 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 CAP.

1.6.1.3. The Contractor shall operate a quality control program; 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. 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 accordance with PRS.

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 CAP and German employee safety standards.

1.8. SECURITY REQUIREMENTS.

1.8.1. Physical Security.

1.8.1.1. All Contractor Employees, to include subcontractor employees, requiring access to Army installations, facilities and controlled access areas shall complete AT Level I awareness training within 20 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 20 calendar days after completion of training by all employees and subcontractor personnel. AT level I awareness training is available at the following website: https://jkodirect.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

1.8.1.3. Contractor and all associated subcontractor 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 DoW, HQDA and/or local policy. In addition to the changes otherwise authorized by the changes clause of this contract, should the Force Protection Condition (FPCON) any individual facility or installation change, the Government may require changes in contractor security matters or processes.

1.8.1.4. Contractor and all associated sub‐contractors employees shallcomply with adjudication standards and procedures using the National Crime Information Center Interstate Identification Index (NCIC‐III) and Terrorist Screening Database (Army Directive 2014‐05/AR 190‐13), applicable installation, facility and area commander installation/facility access and local security policies and procedures (provided by government representative); or, at OCONUS locations, in accordance with status of forces agreements and other theater regulations.

1.8.1.5. DFARS Clause 252.225‐7040, Contractor Personnel Authorized to Accompany U.S. Armed Forces Deployed Outside the United States, shall be used in solicitations and contracts that authorize contractor personnel to accompany US Armed Forces deployed outside the US in contingency operations; humanitarian or peacekeeping operations; or other military operations or exercises, when designated by the combatant commander.

The clause discusses the following AT/OPSEC related topics: required compliance with laws and regulations, pre‐ deployment requirements, required training (per combatant command guidance), and personnel data required.

1.8.1.6. DFARS Clause 252.225‐7043, Antiterrorism/Force Protection for Defense Contractors Outside the US .

The clause shall be used in solicitations and contracts that require performance or delivery in a foreign country. This clause applies to both contingencies and non‐contingency support. The key AT requirement is for non‐local national contractor personnel to comply with theater clearance requirements and allows the combatant commander to exercise oversight to ensure the contractor’ compliance with combatant commander and subordinate task force commander policies and directives.

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 DoW, DHA, U.S. Army, or other Government agency basic policy of initial and periodic security training, and the need for physical controls to protect hardware.

https://jkodirect.jten.mil/

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 2 DEFINITIONS

2. DEFINITIONS/ACRONYMS:

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

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

2.1.9. 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.

2.1.10. 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.

2.1.11. 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.

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

2.1.13. 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.

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

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

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

2.1.17. 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.

AQL - Acceptable Quality Level CAP - College of American Pathologists CFR - Code of Federal Regulations COR - Contracting Officer Representative DHA - Defense Health Agency DoD - Department of Defense DoW - Department of War DPALS - Department of Pathology and Area Laboratory Services HHS - U.S. Department of Health and Human Services HIPAA - Health Insurance Portability & Accountability Act 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 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.

3.1.4. Provide a list of lab designated personnel for Contractors to provide results electronically.

3.1.5. Request supplies needed with consideration of Contractor’s stated lead time.

SECTION 4 CONTRACTOR RESPONSIBILITIES

4. CONTRACTOR-FURNISHED ITEMS

4.1. Catalog of Laboratory Services. The Contractor shall provide both a hard and electronic copy of its Catalog of Services Manual to the COR and designated lab personnel at the start-up period. The manual must be written in English. Examples of the information to be provided include the following:

4.1.1. Test specific specimen collection and preservation requirements.

4.1.2. Test specific method and interpretation.

4.1.3. Test specific method reference ranges.

4.1.4. Test specific method sensitivity, specificity, and interferences.

4.1.5. Test specific schedule of performance and average turnaround time.

4.1.6. Test Order Code

4.1.7. Testing Location

4.2. 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, COR, and designated POCs 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.

4.3. 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.

4.4. MATERIALS/CONSUMABLES.

4.4.1. 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.

4.4.2. The Contractor shall be responsible for providing test-specific collection kits and supplies needed for the shipment of specimens from DPALS to Contractor.

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

4.4.4. 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.

4.4.5. Contractor shall furnish written instructions to Government personnel for requesting supplemental or add-on testing.

4.4.6. The Contractor shall provide test request forms, preprinted with the appropriate Shipping Section and account information for the tests offered. Test request forms for specialized testing (i.e., cytogenetics, tissue, etc.).

4.4.7. Will provide ordering instructions on how to request test-specific collection kits and supplies needed for the shipment of specimens from submitting activity to Contractor.

4.4.8. The cost of the kits and shipping and collection supplies are the responsibility of the Contractor.

4.4.9. Supplies shall be replenished by the Contractor to allow for performance of all contract requirements without interruption.

4.4.10. On a case-by-case basis, emergency supplies may be requested and shall be provided by the Contractor as required.

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

SECTION 5 DESCRIPTION OF WORK

5. SPECIFIC TASKS

5.1. COURIER. The Contractor shall provide specimen pick up, via Courier, from LRMC, 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 routine local courier pick-up services on a daily basis (Monday – Friday, excluding German and U.S. Federal holidays) at a time mutually agreed upon by the COR and the Contractor.

5.1.2. If the electronic reporting requirements of this contract are temporarily unavailable for use, the Contractor shall provide expedited overnight courier mailing, and/or transportation services of printed reports of completed test results.

5.1.3. The courier will transport specimens under required conditions to ensure viability and stability for testing.

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

5.3. CATALOG OF LABORATORY SERVICES. The Contractor shall provide a comprehensive hard copy catalog and an electronic version/website of the catalog to designated laboratory personnel and COR. The catalog shall be provided at time of award. The 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 will contain the items listed in paragraph 4.1.

5.3.1. The contractor shall ensure notification is performed within 15 calendar days prior to any methodology changes.

5.4. TESTING. The Contractor shall perform clinical reference laboratory testing and provide services required to perform testing to include but not limited to, supplies, labor, software, and result reporting/interpreting. The

Contractor shall be CAP accredited. Contractor shall inform the COR of any delays expected to increase the result turnaround time beyond 72 hours via telephone and e-mail.

5.4.1. 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.

5.4.2. CONFIRMATORY TESTING. If confirmatory testing is necessary, the Contractor shall perform the additional confirmatory testing, upon written approval.

5.4.3. AMENDED RESULTS. Amended results shall be telephoned directly to designated laboratory personnel after being confirmed and certified by the Contractor, in accordance with Contractor’s stated procedure. The telephonic report shall be followed by an electronic transmission.

5.4.3.1. Amended results must also be flagged and copies of revised reports must be provided to the POCs. The report shall be an individualized chartable patient report.

5.5. HANDLING OF SPECIMEN OR REQUEST DISCREPANCIES.

5.5.1. Specimen loss due to breakage, spillage/leakage, misplacement, mishandling or any other Contractor related problem(s) shall be reported immediately to DPALS upon knowledge or detection of problem. Repeated problems with compromised specimens may be grounds for termination for cause of the contract.

5.5.2. Any specimens that have been broken, leaked, or otherwise compromised during transit shall be immediately reported to DPALS upon unpacking at the Contractor’s laboratory.

5.6. SUPPLIES.

5.6.1. Then Contractor shall provide and replenish test specific collection kits to allow for performance of all contract requirements without interruption.

5.7 CONTRACTOR LABORATORY INFORMATION SYSTEM.

5.7.1 The Contractor shall provide and maintain a self-maintained, secure internet website or laboratory information system for rapid retrieval and printing of laboratory results including a description of use. The Contractor shall maintain the test results in accordance with appropriate regulatory/accrediting agency guidelines.

5.7.1.1 The Contractor shall comply with the document entitled ‘Personally Identifiable Information (PII), Protected Health Information (PHI) and Federal Information Requirements,’ which is incorporated by reference in its entirety.

5.7.2 The Contractor's automation shall provide:

5.7.2.1 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.

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

5.7.2.3 Once corrective actions have been taken or resolved and testing resumed, test results shall be made available immediately upon completion of review.

5.7.2.4 Online Test Menu Catalog. The test menu catalog will be used by the government as a reference to https://health.mil/Reference-Center/Forms/2020/10/27/DHA-Privacy-Office-Standard-Contract-Language https://health.mil/Reference-Center/Forms/2020/10/27/DHA-Privacy-Office-Standard-Contract-Language determine the specimen requirements, methodology and clinical utility of all the tests offered by the contractor. On-line access to detailed reference data, such as might be normally available through a hardcopy. Such data shall include all items listed in paragraph 4.1.

5.7.2.5 Patient Information Backup Capability. The information system shall have the ability to develop and maintain backup patient information and shall be available on a daily basis, including test results processed.

5.7.2.6 Abnormal results (results outside the reference range) shall be flagged by some indication on the reports to differentiate them from normal results (results within the reference range) and reported to DPALS immediately.

5.8 SPECIMEN RETENTION.

5.8.1 Specimens shall be stored/retained by the Contractor for at least 7 days after the reporting of the results. In selected cases, and upon request by a site, the Contractor shall store/retain specimens for up to 30 days at no additional cost.

5.9 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.

5.10 RESULTS REPORTING.

5.10.1 The Contractor shall make test results available within 72 hours of specimen receipt except for tests that have a greater published turnaround time. The Contractor shall report results via a secure internet website made accessible to designated laboratory personnel. In the event that the results cannot be reported electronically, the Contractor shall contact DPALS to determine a course of action.

5.10.2 Abnormal results (results outside the reference range), or incomplete testing shall be flagged by some indication on the reports to differentiate them from normal results (results within the reference range). Reports shall be released by the Contractor, even if all of the results in each batch have not been completed within the run, with the understanding that when incomplete tests are completed, reports shall be made available to the submitting facility.

5.10.3 In cases of malfunction of the Contractor-supplied electronic reporting method lasting more than 24 hours, the Contractor shall, without additional charge, provide express overnight shipping or courier delivery of printed reports to the COR until the automated information system is properly functioning.

5.11 MANAGEMENT REPORTS.

5.11.1 Monthly Utilization Reports. The Contractor shall provide separate monthly data summary reports of tests performed to the COR. The reports shall be delivered to the COR as identified on the contract, by the tenth calendar day of the month after the end of each monthly reporting period, in a secured method as agreed upon between COR and Contractor.

5.11.1.1 The reported information shall include subtotals for each test and the test name, vendor's test code, test cost, number of tests performed (current month), total monthly cost (per test).

5.11.1.2 Upon request, the vendor will provide a year to date workload and cost per test report.

5.11.1.3 Notification of when a specific test is subject to a unit price change shall be provided by the Contractor to the Contracting Officer. Identify the test name, vendor's test code, and revised unit cost per test.

5.11.1.4 All reports shall be submitted in electronic form. Electronic supplemental narrative shall be forwarded as appropriate.

5.12 MISCELLANEOUS CONTRACTOR RESPONSIBILITIES.

5.12.1 The Contractor shall keep the contracting officer and the COR, informed of the most recent developments in clinical laboratory methods used and medical interpretation of laboratory tests through periodic newsletters, reports, data sheets, and/or Continuing Medical Education (CME) presentations. The Contractor shall provide quarterly updates.

5.13 CONTRACT START-UP PERIOD.

5.13.1 Immediately upon award, there will be a start-up period consisting of a maximum of 30 calendar days. The intent of this start-up period is to enhance coordination between the Government and the Contractor in order to avoid misunderstanding or mistakes on the part of both parties. The Contractor shall provide the necessary personnel required to perform training/orientation with coordination from the COR. During this period, the following shall take place:

5.13.2 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.

5.13.3 The Contractor shall provide materials and supplies needed for shipment of specimens from designated laboratory personnel to Contractor.

5.13.4 The Contractor shall provide designated laboratory personnel with processing and shipping information and their commercial client services manual during the start-up period.

SECTION 6 Applicable Regulations, Manuals, Technical Documents, Specifications, and Forms

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

6.7 The following is a list of basic publications applicable to this contract (Current Editions). Current issues of many DA publications and forms can be accessed at https://armypubs.army.mil. Publications and forms not on the internet can be obtained from LRMC.

AR 25-22 The Army Privacy and Civil Liberties Program AR 40-3 Medical, Dental, and Veterinary Care, Chapter 5, Army Blood Programs AR 40-66 Medical Record Administration and Health Care Documentation AR 190-17 Biological Select Agents and Toxins Security Program AR 200-1 Environmental Protection and Enhancement AR 380-5 Army Information Security Program ARMY DIR 2016-24 Department of Defense Biological Select Agent and Toxins Biosafety Program DA PAM 25-403 Guide to Record Keeping in the Army DA PAM 385-61 Toxic Chemical Agent Safety Standards Title 29 CFR, Part 1910 Occupational Safety and Health Standards

(End of Performance Work Statement) https://armypubs.army.mil/