PWS Medical Laboratory Svcs Updated 30 Dec 2024.pdf

PERFORMANCE WORK STATEMENT (PWS)

FOR

MUNIZ AIR NATIONAL GUARD BASE, PUERTO RICO (MANGB)

MEDICAL LABORATORY SERVICES

1.0 General:

1.1 Scope. The contractor shall provide all personnel, equipment, tools, materials, supervision, and quality control necessary to perform medical laboratory services to support Muñiz Air National Guard Base (ANGB), Puerto Rico, as defined in this PWS. Services include but are not limited to the collection, detailed analysis, and electronic reporting of clinical laboratory tests, ensuring accurate and timely results to support patient care. All test results must be sent electronically via email to the designated medical personnel. The contractor shall perform to the standards in this contract.

1.2 Background. In accordance with DoD and Air Force Policy, service members, as a conditioned of continued participation in military service, are required to maintain to their individual medical readiness requirements, which validate their medical readiness for deployment. The DoD and Air Force must adhere to Occupational Safety and Health Administration standards to protect individuals in the work environment. The Government requires professional medical laboratory services to support the healthcare needs of personnel assigned to Muñiz ANGB, PR.

The contractor’s staff must be fully qualified, professional, and customer-service oriented. The contractor shall ensure quality work performance in accordance with applicable standards and guidelines, including but not limited to CLIA, CAP, and OSHA standards. Additionally, the contractor is expected to continuously improve the quality of programs and services offered to customers.

1.3 Period of Performance (PoP). Services shall begin upon contract award and continue for a period of 60 calendar months with options to extend based on performance and funding availability.

1.4 General Information:

1.4.1 Quality Control (QC). The contractor shall develop and maintain an effective QC Plan (QCP) to ensure services are performed IAW this PWS. The contractor shall develop and implement procedures to identify, prevent, and ensure non-recurrence of defective services. The contractor’s QCP is the means by which it assures itself that its work complies with the requirements of the contract. As a minimum, the contractor shall develop QC procedures that address the areas identified in Technical Exhibit 1, Performance Requirements Summary. A written copy of the contractor’s QCP shall be furnished to the Contracting Officer (KO) at the pre-performance meeting. Records of the contractor’s quality inspections shall be maintained for the life of the contract and made available for Government inspection as requested. The Government evaluator must have a specific contractor quality control inspector to notify in case of customer complaints. After acceptance of the QCP, the contractor shall obtain the KO’s acceptance in writing of any proposed changes to its QCP.

(Technical Exhibit 2)

1.4.2 Quality Assurance (QA). The Government shall evaluate the contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan (QASP). This plan defines how the performance standards will be applied, the frequency of surveillance, and acceptable quality levels/defect rates.

1.4.2.1 Government remedies. The KO will follow the requirements of FAR 52.246-4, Inspection of Services – Fixed-Price, for contractor’s failure to correct non-conforming services. In the event that services fail to conform to contract requirements, and cannot be remedied by re-performance, the Government reserves the right to reduce the contract price to reflect the reduced value of the non-conforming services.

1.4.2.1.1 The contractor shall ensure that timely and effective corrective action is obtained for all deficiencies identified by the Government. All deficiency responses shall include identification of the cause of the deficiency to preclude recurrence and an analysis of the quality program’s effectiveness in the area of the deficiency.

1.4.3 Recognized Holidays. The contractor is not required to work during Federal Holidays. The following are recognized US holidays.

New Year’s Day 1 January Martin Luther King, Jr.’s Birthday 3rd Monday in January Presidents Day 3rd Monday in February Memorial Day Last Monday in May Independence Day 4 July Labor Day 1st Monday in September Columbus Day 2nd Monday in October Veterans Day 11 November Thanksgiving Day 4th Thursday in November Christmas Day 25 December

1.4.3.1 When the holiday falls on a Saturday, the observed day shall be on the prior Friday. When the holiday falls on a Sunday, the observed day shall be on the following Monday.

1.4.4 Place and Performance of Services: The contractor shall provide services between the hours of 0730-1630 on Monday through Saturday, except on recognized US holidays. The contractor shall maintain an adequate work force for the uninterrupted performance of all tasks defined within this PWS. When hiring personnel, the contractor shall keep in mind that the stability and continuity of the work force are essential. The required distance should be no greater than 15-20 minutes from the 156th Wing and within the San Juan-Carolina area.

1.4.4.1 The contractor may request permission to work outside these hours by obtaining approval from the KO at no additional cost to the Government (includes weekends and extended daily work hours). Overtime and/or weekend, or holiday work typically involves internal extra costs to the Government for overtime inspection and utilities, and generally is not approved unless determined to be absolutely necessary to sustain mission critical facilities.

1.4.4.5 Employee Training. The contractor is responsible for providing a fully trained and qualified workforce.

Therefore, except as otherwise indicated, the contractor shall train, qualify, and certify personnel for specific job tasks to be performed at its own expense. Records of training, qualification, and certification shall be maintained by the contractor and made available for Government review upon request.

1.4.5 Security Requirements. No contractor will require access to the military installation. All military members will go to the laboratory facility to undergo the required testing.

1.4.5.1 COMSEC/IT Security. All communications with DoD organizations are subject to communications security (COMSEC) review. All telephone communications networks are continually subject to intercept by unfriendly intelligence organizations. DoD has authorized the military departments to conduct COMSEC monitoring and recording of telephone calls originating from, or terminating at, DoD organizations. Therefore, the contractor is advised that any time contractors place or receive a call they are subject to COMSEC procedures. The contractor shall ensure wide and frequent dissemination of the above information to all employees dealing with DoD information.

1.4.5.2 Protection of Personally Identifiable Information (PII). The contractor shall protect all PII encountered in the performance of services IAW DFARS 224.103 and DoDD 5400.11, Department of Defense Privacy Program, and DoD 5400.11-R. If a PII breach results from the contractor’s violation of the aforementioned policies, the contractor shall bear all notification costs, call-center support costs, and credit monitoring service costs for all individuals whose PII has been compromised.

1.4.6 Safety/Environmental: The contractor shall comply with OSHA and all other applicable federal, state, and local regulations concerning safety and environmental protection. All incidents and accidents must be reported immediately to the Government representative.

1.4.6.1 Accident prevention and safety practices on contractual work under the jurisdiction of the Contracting Officer are the responsibilities of the contractor concerned. The contractor shall brief all employees on proper safety and accident reporting. The contractor shall provide all occupational health services to his employees. Contractor employees shall be instructed to notify the contractor’s Contract Manager of potential or existing occupational health hazards that require attention.

1.4.6.2 Liability. The contractor hereby agrees to release the Government (to include its officer, enlisted personnel, agents, and employees) from any liability for any loss, damage, or injury sustained by the contractor or his employees during the performance of this contract. The contractor also agrees to indemnify the Government for any loss, damage, or injury to Government personnel or agents or other third parties, provided such loss to the Government is caused by the negligence of the contractor or his personnel while performing this contract.

1.4.6.3 Handling, Storage and Disposal of Hazardous Waste (HW). All HW shall be handled and stored in strict compliance with federal, state and, local regulations. Contractors will be held fully liable for any negligence that results in a Notice of Violation or other penalty. HW will be defined as a solid or liquid waste which exhibits a characteristic such as flammability, corrosivity, reactivity, or toxicity, as identified in 40CFR 261.20-261.33 (Code of Federal Regulations: Discarded commercial chemical products, off-specification species, container residues, and spill residues). Any mixture of a solid or liquid waste and a listed HW is also considered a HW. It must be understood that proper management of any waste generated, hazardous or non-hazardous, shall and will be the responsibility of the contractor. Any Government owned shipment of HW shall be documented on a HW Manifest and signed by a Civil Engineering Environmental Office representative. A copy of the generators’ manifest shall be maintained by the 156th Civil Engineering Squadron/ Environmental Management Office.

1.4.7 The contractor shall comply with the requirements of the Air Force Affirmative Procurement Program and EPA’s Comprehensive Procurement Guideline and Recovered Materials Advisory Notice contained therein, and the installation Affirmative Procurement Program. Affirmative Procurement is the purchase of supplies and services containing post-consumer, recycled or recovered materials. The contractor shall support the program by identifying, pursuing, and tracking the procurement of these items where applicable.

1.4.8 Special Qualifications:

1.4.8.1 All contractor personnel must possess appropriate certifications and licensure to perform medical laboratory testing. The contractor shall ensure all staff are proficient in English.

1.4.8.2 The contractor is required to ensure that all laboratory test results are detailed and comprehensive, including all necessary data to support clinical decision-making. These results must be electronically sent via email to the designated medical personnel promptly upon completion of the tests.

1.4.9 Post Award Conference/Periodic Progress Meetings: The contractor agrees to attend any post award conference convened by the KO in accordance with FAR Subpart 42.5. The KO, Contracting Officer’s Representative (COR), and other Government personnel, as appropriate, may meet periodically with the contractor to review the contactor’s performance. At these meetings, the KO will apprise the contractor of how the Government views the contractor’s performance and the contractor shall apprise the Government of problems, if any, being experienced the contractor shall resolve outstanding issues raised by the Government. Contractor attendance at these meetings shall be at no additional cost to the Government.

1.4.9.1 Government Observations and Inspections. Government personnel other than KOs and CORs may occasionally observe contract operations. These personnel will not, however, interfere nor provide direction to the contractors’ performance.

1.4.10 Contract Manager (CM): The contactor shall provide a CM who shall ensure performance under this contract. The name of this person, and an alternate who shall act for the contractor when the CM is absent, shall be designated in writing to the KO. The CM or alternate shall have full authority to act for the contractor on all contract matters relating to daily operation of this contract. The CM shall work through the COR, or the KO if a COR is not available, to resolve issues, receive directions and ensure adequate performance of services. The CM shall ensure that contractor employees do not perform any services outside the scope of the contract without an official modification issued by the KO. The CM shall ensure contractor employees understand that services performed outside the scope of the contract are performed wholly at the expense of the contractor.

1.4.10.2 Performance Evaluation Meetings. The KO will require the CM to meet with the KO, CS, COR, and other Government personnel as deemed necessary. These meetings shall be held weekly for the first month of the contract and monthly thereafter, or as determined by the KO. The purpose of these meetings is to establish a partnership to resolve issues. Written minutes of any such meeting shall be recorded in the contract and distributed to all interested parties.

1.4.11 Contractor Employees. The contractor shall employ only personnel who meet or exceed minimum qualifications. Resumes/additional documentations for personnel proposed to fill the CM position shall be provided to the KO at the pre-performance conference. Documentation shall also be provided during the contract performance should any changed in personnel be made. The contractor shall not employ persons for work on this contract if such employee is identified to the contractor by the KO as a potential threat to the health, safety, security, general well-being, or operational mission of the installation and its population.

1.4.11.1 The contractor’s staff shall be fully qualified, professional, and customer service oriented. The contractor shall ensure quality work performance IAW applicable standards and guidelines. Additionally, the contractor is expected to be a partner with the base community in continuously improving the quality of programs and service offered to customers.

1.4.11.2 Identification of Contractor Employees: All contractor personnel are required to identify themselves as such to avoid creating an impression that they are Government employees. Contractor personnel shall present a neat appearance and wear identification badges distinguishing themselves as such. The badges shall have the company name, employee name and the word “contractor” displayed.

1.4.12 Combating Trafficking in Persons: The United States Government has adopted a zero-tolerance policy regarding trafficking in persons. Contractors and contractor employees shall not engage in any form of trafficking in persons during the period of performance of the contract; procure commercial sex acts during the period of performance of the contract; or use forced labor in the performance of the contract. The contractor shall notify its employees of the United States Government’s zero tolerance policy, the actions that will be taken against employees for violations of this policy. Such actions may include, but are not limited to, removal from the contract, reduction in benefits, or termination of employment. The contractor shall take appropriate action, up to and including termination, against employees or subcontractors that violate the US Government policy as described at FAR 22.17.

1.4.13 Conservation of Utilities. The contractor shall ensure employees practice utilities conservation. Service problems shall be immediately identified to the COR.

1.4.14 Coordination with Other Contractors. The Government may award other contracts or additional work not prescribed in this contract. The contractor shall fully cooperate with other such contractors. The contractor shall not commit or permit any act that will interfere with the performance of work by another contractor.

1.4.15 The contractor may propose substitutions for the Government’s consideration for any equipment and software for any provided product(s) that may become available as a result of technical improvements, to include billing administration and processing services.

2.1 CONTRACTOR. A supplier or vendor awarded a contract to provide specific supplies or service to the Government. The term used in this contract refers to the prime.

2.2 CONTRACTING OFFICER (KO). A person with authority to enter into, administer, and or terminate contracts, and make related determinations and findings on behalf of the Government. Note: The only individual who can legally bind the Government.

2.3 CONTRACTING OFFICER'S REPRESENTATIVE (COR). An employee of the U.S. Government designated by the KO to monitor contractor performance. 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.

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

2.5 DELIVERABLE. Anything that can be physically delivered and includes non-manufactured things such as meeting minutes or reports.

2.6 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 proposal.

2.8 QUALITY ASSURANCE (QA). The Government procedures to verify that services being performed by the contractor are performed according to acceptable standards.

2.9 QUALITY ASSURANCE SURVEILLANCE PLAN (QASP). An organized written document specifying the surveillance methodology to be used for surveillance of contractor performance.

2.10 QUALITY CONTROL (QC). All necessary measures taken by the contractor to assure that the quality of an end product or service shall meet contract requirements.

2.11 SUBCONTRACTOR. One that enters into a contract with a prime contractor. The Government does not have privity of contract with the subcontractor.

2.12 WORK DAY. The number of hours per day the contractor provides services in accordance with the contract.

2.13 WORK WEEK. Monday through Friday, unless specified otherwise.

2.14 ACRONYMS: Following are acronyms commonly used in DoD contracts.

ADLS Advanced Distribution Learning System AF Air Force AFI Air Force Instruction AFMAN Air Force Manual ANG Air National Guard AT/OPSEC Antiterrorism/Operational Security CAC Common Access Card CFR Code of Federal Regulations CM Contract Manager CMRA Contractor Manpower Reporting Application COD Certificate of Destruction COMSEC Communications Security COR Contracting Officer Representative COTS Commercial-Off-The-Shelf CPARS Contract performance reporting system CS Contract Specialist DD254 Department of Defense Contract Security Requirement List DEERS Defense Enrollment Eligibility Reporting System DFARS Defense Federal Acquisition Regulation Supplement DFAS Defense Finance and Accounting System DOD Department of Defense FAR Federal Acquisition Regulation FPCON Force Protection Condition GFP/M/E/S Government Furnished Property/Material/Equipment/Services IA Information Assurance

IAW In Accordance With IS / IT Information System(s) / Information Technology KO Contracting Officer MSDS Material Safety Data Sheets NHO Normal hours of operation NOTAM Notice to Airmen OCI Organizational Conflict of Interest ODC Other Direct Costs OPM Office of Personnel Management OPSEC Operations Security OSHA Occupational Safety and Health Standards PII Personally Identifiable Information PIPO Phase In/Phase Out PIV Personal Identity Verification PKI Public Key Infrastructure POC Point of Contact PoP Period of Performance PRS Performance Requirements Summary PWS Performance Work Statement QA Quality Assurance QAP Quality Assurance Program QASP Quality Assurance Surveillance Plan QC Quality Control QCP Quality Control Program RC Records Custodian MANGB Muñiz Air National Guard Base TA Trusted Agent TASS Trusted Associate Sponsorship System TE Technical Exhibit UIC Unit Identification Code UCI Unit Compliance Inspection WBT Web Based Training

3.0 FEDERAL ACQUISITION REGULATION (FAR)

3.1 This Performance Work Statement does not supersede any FAR stipulations that may appear in this contract. For more up to date information visit https://www.acquisition.gov/browse/index/far.

4.0 COMPLIANCE

4.1 Compliance with Standards: Adherence to all relevant regulations, including CLIA, CAP, OSHA, and other

Air Force applicable standards. Regulations and all applicable Federal and State Regulations.

4.2 Contractor must be registered (current) in the System for Award Management (SAM) internet program at http://www.sam.gov.

4.3 All invoices must be submitted using Wide Area Workflow (WAWF) internet program and verify the statuses at https://wawf.eb.mil.

5.0 Requirements:

Medical laboratory list of services

1. Hematology

- Complete Blood Count (CBC)

- Hemoglobin Electrophoresis

2. Clinical Chemistry

- Basic Metabolic Panel (BMP)

- Comprehensive Metabolic Panel (CMP)

- Liver Function Tests (LFTs)

- Lipid Panel (Cholesterol, Triglycerides)

- Blood Glucose Testing (Fasting, Random, HbA1c)

- Glucose-6-phosphate dehydrogenase (G6PD)

- Sickel cell

- Liver function (ALT/ GGT/ AST)

3. Microbiology

- None

4. Immunology and Serology

- Hepatitis Panel (A, B, C)

- Syphilis Testing (VDRL, RPR)

5. Molecular Diagnostics

- None

6. Blood Bank & Transfusion Services

- Blood Typing (ABO, Rh)

- Antibody Screening

7. Urinalysis

- Routine Urine Examination (Physical, Chemical, Microscopic)

- Urine Pregnancy Test (hCG)

8. Endocrinology

- None

9. Toxicology

- Alcohol Testing

- Heavy Metal Screening (Lead, Mercury)

10. Infectious Disease Testing

- None

11. RESERVED

5.1 Accuracy of Results: The precision and reliability of the laboratory tests performed, as reflected in the detailed reports shall be accurate within acceptable tolerance standards.

5.2 Timeliness: The promptness in which laboratory tests are completed and results are sent electronically to the designated personnel shall adhere to mandatory industry timelines.

5.3 Customer Satisfaction: Feedback from the medical personnel regarding the clarity, thoroughness, and utility of the laboratory results will be evaluated following customer complaints.

5.4 Compliance with Standards: Adherence to all relevant regulations, including CLIA, CAP, OSHA, and other Air Force applicable standards.

TECHNICAL EXHIBIT 1

Performance Requirements Summary

This Performance Requirements Summary includes performance standards. The Government will use these standards to determine contractor performance and will compare contractor performance to the Acceptable Quality Level (AQL).

Task Performance Standard Acceptable Quality

Levels (AQL) Surveillance Method

By

(5.1) Accuracy of Results

The precision and reliability of the laboratory tests performed, as reflected in the detailed reports.

- Error tolerance: No more than 2 error per 1,000 tests.

- Accuracy threshold: no less than 98%.

- Accuracy audits will be conducted every three months.

- Corrective action trigger will be 1% in any given month.

Periodic Inspection

(5.2) Timeliness

The promptness with which laboratory tests are completed and results are sent electronically to the designated personnel.

- Laboratory results should be completed and sent electronically to designated personnel no later than 7 calendar days

Periodic Inspection

(5.3) Customer Satisfaction

Feedback from the medical personnel regarding the clarity, thoroughness, and utility of the laboratory results.

- Feedback from medical personnel regarding clarity and thoroughness of results.

Customer Complaint

(5.4) Compliance with Standards

Adherence to all relevant regulations, including CLIA, CAP, OSHA, and other Air Force applicable standards.

- Adherence to Air Force regulations and with CLIA, CAP, and OSHA.

Management Information

TECHNICAL EXHIBIT 2

Applicable Publications

Publications applicable to this (PWS) are listed below

Publication Date of

Publication

Mandatory

/Advisory Website

DHA-PI 6490.03

December 17, Mandatory https://health.mil/Reference-Center/DHA- Publications/2019/12/17/DHA-PI-6490-03

AFI 10-250

July 22, 2020 https://www.e-publishing.af.mil/

DAFMAN

48-123

8 Dec 2020 https://www.e-publishing.af.mil/

TECHNICAL EXHIBIT 3

Submittal List Description

Description Type QTY Due Remarks

Monthly account statement, breaking down billing activity from tests performed

Standard Business System monthly statement each

No later than 7 days after the end of each month

Must be received by:

MSgt Eduardo Rivera and CMSgt Hector Garcia

Quality Assurance Plan

AF Form

Approved 7 days after award

Must be signed by:

MSgt Eduardo Rivera or CMSgt Hector Garcia and KO