2. PWS 3-17-2023.pdf

Attachment 2 to FA4664-23-Q-0009

Performance Work Statement (PWS)

Laboratory Testing Services

452 Aerospace Medicine Squadron (AMDS)

March ARB, California

17 March 2023

1.0 DESCRIPTION OF SERVICES.

1.1 Scope. This Performance-based Work Statement (PWS) describes the services required to/for processing laboratory specimens for individual readiness requirements. These services include specimen pick-up, specimen processing, result delivery, and patient information and/or results upkeep. Due to potential sample stability/shipping issues, strict and expensive shipping requirements, and longer specimen result turn-around-times, using a local clinical reference laboratory is a best means approach to maintaining individual and wing readiness for mission accomplishment.

1.2 Non-Personal Services. The 452 AMDS will neither supervise Contractor personnel nor control the method by which the Contractor performs the required tasks. Under no circumstances shall the 452 AMDS assign tasks to, or prepare work schedules for, individual contractor personnel. It shall be the responsibility of the Contractor to manage its personnel and to guard against any actions that are of the nature of personal services or give the perception of personal services. The Contractor shall notify the Contracting Office/Contracting Officer (KO) immediately if any task requires action by the Contractor personnel that constitutes or are perceived to constitute personal services. These services shall not be used to perform work of a policy/decision making or management nature, i.e., inherently governmental functions.

1.3 Organization. The organization with primary responsibility for this requirement is 452 Aerospace Medicine Squadron.

1.4 Place of Performance. All tests shall be executed at the Contractor’s premises, or within the Contractor’s network of laboratories [affiliate(s) or qualified subcontractor(s)].

1.5 Required Services.

1.5.1 Contractor shall provide courier service for secure laboratory specimen transport available seven days a week between the hours of 8:00 a.m. and 4:00 p.m. Excludes federal holidays. The Contractor is not required to provide service on the following recognized federal holidays:

• New Year’s Day

• Martin Luther King’s Birthday

• Presidents Day

• Memorial Day

• Juneteenth

• Independence Day

• Labor Day

• Columbus Day

• Veterans Day

• Thanksgiving Day

• Christmas Day

1.5.2 All testing equipment, associated personnel, materials, and supplies needed to process/test patient specimens shall be provided by the Contractor.

1.5.3 Contractor shall process, test, and result all received specimens in a timely manner and in compliance with Contractor’s accrediting agency(s) and state standards/guidelines.

1.5.4 All patient results shall be maintained by the Contractor no less than two years and be available during this time upon request of the 452 AMDS (CLIA 493.1105).

1.5.5 Contractor shall provide the 452 AMDS with a monthly itemized record of services rendered (para 2.5) and emailed to Technical POC no later than the 15th of the following month.

2.0 SERVICES SUMMARY (SS).

2.1 Once specimens are ready for transport to the Contractor, the 452 AMDS will notify the Contractor and set up a pick-up date/time in accordance with (IAW) section 1.5 Required Services para 1.5.1. The 452 AMDS will notify the Contractor and provide a contact number that will be relayed to the courier and used when the courier is in route and/or currently awaiting specimens at the March ARB Visitor Control Center. There will be at least a 15-minute window from the time the courier reaches the visitors center to when a laboratory services representative meets and delivers specimens to the courier. The courier will supply the needed transport devices, if applicable, to safely deliver the specimens to the Contractor.

Laboratories using third-party private couriers are responsible for ensuring that laboratory specimens are packaged and transported properly. At no time will the courier be asked or expected to attempt base entry.

2.2 Contractor has on-site or available all means to process all applicable tests needed by the 452 AMDS to maintain laboratory associated readiness requirements. These tests include:

ABO/Rh G6PD Sickle Cell Screen Glucose (serum) Hepatic Function Panel Lipid Panel w/ reflex to DLDL hCG, Total, Qualitative CBC (includes Diff & Platelets) RPR w/ reflex to Titer & Conf Alcohol, Ethyl Lead (Venous) Fecal Globin (InSure) Urinalysis w/ reflex microscopic

The Contractor shall provide in accordance with all applicable federal and state regulations, laws, and ordinances, and in accordance with the specifications outlined for accreditation certification, patient specimen testing for the specific range of referral testing within their capability.

2.3 The Contractor shall make available a web based online account for all 452 AMDS laboratory personnel and designees. The Contractor shall provide, at a minimum, the Technical POC or designee an in-service training required for the use of the Contractor’s test ordering and result management system. The training will ensure that 452 AMDS staff can perform routine test ordering and result retrieval and/or retransmission of test orders and results.

2.3.1 The web based online account must allow each user to:

• Register new patients/Look up existing patients.

• Search and order tests.

• Print copies of laboratory reports/results.

• Order and track supplies (if applicable, either through primary or secondary website).

2.4 Test results will be recovered by the 452 AMDS through the Contractor's website or available by mail or facsimile if requested. Patient reports will be available by the Contractor for no less than 2 years. A report is defined as a printed or electronic final copy of laboratory testing results.

Each test report shall indicate, at a minimum, the following information:

Patient’s name Social Security Number of DOD ID Type of specimen Date/time of specimen collection Test(s) ordered Date/time specimen received in Reference Lab Test result and unit of measure (when applicable) Reference range (when applicable) Flag abnormals Date test completed Name and address of testing laboratory

*NOTE* Any other information the laboratory has that may indicate a questionable validity of test results. Unsatisfactory specimens shall be reported with regards to its unsuitability for testing.

*NOTE* There is no compatible laboratory information system (LIS) available at March ARB meaning the Contractor shall not need any special Government related computer communication access or permissions.

2.5 Due to specimen stability, some tests requiring analysis within 48 hours, it is imperative to utilize a reference laboratory that lessens the risk of specimen transport and testing delay, while providing an easier course correction/resolution should issues arise. The Contractor shall receive, process, test, and result all 452 AMDS specimens in a timely manner and according to established guidelines. The Contractor shall provide routine test results to the 452 AMDS within 24 hours following test completion. Test procedures requiring a turnaround time longer than 24 hours shall be identified in the Contractor’s Laboratory User’s manual (paper, electronic, or on-line).

Contractor shall contact the 452 AMDS as soon as made aware when a specimen needs recollected, results cannot be released without patient identity verification, or any other issue that will potentially delay patient care and mission readiness. Critical values, consistent with Contractor’s published Critical Values policies, shall be called immediately to the 452 AMDS laboratory or designee with a read back verification and documentation. Contractor shall store all clinical specimens after all testing has been completed for seven (7) days.

2.6 The Contractor shall provide to the 452 AMDS laboratory or designee a monthly report of all tests received during the month and for all outstanding results. The summary must include the facility account number, alphabetical listing of test names, orderable test codes, and monthly test volumes for each test. The report will also include turnaround statistics, cost per test (including any additional charges), and specimen or testing issues.

2.7 The following table outlines performance objectives that will be used to measure Contractor adherence to the items covered in the Services Summary:

Performance Objectives PWS Para Performance Threshold

SS-1. Service: Provide Routine laboratory testing and result reporting

2.2, 2.3, 2.4, 2.5 Acceptable Quality Level: 90%

Surveillance Method: Monitor services and report any missed pick up or delivery timelines

SS-2. Specimen handling:

Specimens are transported and stored properly

2.1, 2.2, 2.5 Acceptable Quality Level: 95%

Surveillance Method: Monitor services and monthly reports

SS-3. Documentation: Monthly report receipt

2.6 Acceptable Quality Level: 100%

Surveillance Method: Monthly report inspections

SS-4. Certification Requirements:

CLIA, CAP and/or TJC

2.2, 3.1 Acceptable Quality Level: 100%

Surveillance Method: 100% Annual Inspection. Ensure vendor compliance

SS-5. Quality Control Plan:

Contractor shall maintain a quality control program to ensure requirements meet established standards

3.4.2 Acceptable Quality Level: 85%

Surveillance Method: Periodic inspection to ensure Contractor compliance

3.0 GENERAL REQUIREMENTS

3.1. All laboratory testing staff shall comply with minimum Federal, State, and local law qualifications/requirements. The laboratory shall hold 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 laboratory is located. Any subcontractors performing services hereunder shall meet the same requirements as the primary Contractor.

Proof of the above required certification(s), accreditation(s), license(s), etc., shall be furnished to the 452 AMDS.

3.2. Validation of qualification, licensor, and certification (as applicable). The Contractor shall provide written verification (and photocopies where necessary) showing required certification(s), accreditation(s), license(s), etc. and shall be furnished to the 452 AMDS/SGP via contracting officer within 3-business days of any changes and prior to performing any services under this contract for the Prime and subcontractor.

3.3. Any price changes or additional costs not covered in contract can only be approved/authorized by the KO.

3.4. The Contractor shall provide point of contact (POC) who shall be responsible for the performance of work. The name of the POC and the alternate(s) who shall act for the Contractor when the POC is absent shall be designated in writing to the KO within 2 days of contract award.

3.5. Quality Control. The basic quality management system must provide for the appropriate controls of service characteristics and attributes during performance and include inspection and test/criteria/methodology/data that is used to verify/validate conformance to acceptance criteria established for the contract. It should describe specific policies, procedures, and practices and identify quality responsibilities for all operational interfaces.

3.5.1. The Contractor shall successfully perform external proficiency testing surveys as required by CLIA (Clinical Laboratory Improvement Amendment of 1988) for all regulated analytes.

Upon request, the Contractor shall provide the KO or laboratory POC 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 KO or laboratory POC upon request.

3.5.2. The Contractor shall operate a successful quality control program as required by CLIA and CAP (College of American Pathologists). Current CLIA requirements are located at the Health Care Financing Administration’s website: http://www.cdc.gov/clia/. Upon request of the Contracting Office, the Contractor shall provide documentation of quality control 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.

3.6. Quality Assurance. The 452 AMDS will evaluate the Contractor’s performance under this contract. 452 AMDS personnel will record all surveillance observations. When an observation indicates defective performance, the KO personnel will notify the Contractor, the POC or the alternate.

http://www.cdc.gov/clia/

3.7. Reference Manual. The Contractor shall provide a hardcopy reference manual/laboratory guide or online access to equivalent detailed reference data. Such data might include: the test description and its requirements, methodology used to perform the test, schedule for test performance (if any), and date the test was last changed (i.e., incorporation of regulatory changes).

3.8. HIPAA. All contracted management staff performing services for the Air Force have been trained and/or familiar with HIPAA Privacy & Security Rule and will be held accountable for complying with health information privacy and security policies and procedures. Reference HIPAA of 1996 for detailed language.