PWS Laboratory Testing Services v7 dtd 20230719 (Final).pdf

PERFORMANCE WORK STATEMENT (PWS)

FOR

LABORATORY TESTING SERVICES

452d Aerospace Medicine Squadron (AMDS)

March ARB, California

19 July 2023

1. DESCRIPTION OF SERVICES:

1.1. Scope. This Performance Work Statement (PWS) describes the services required for processing laboratory specimens regarding 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 or shipping issues, strict and expensive shipping requirements, and longer specimen result turnaround 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 Aerospace Medicine Squadron (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 a personal services nature or give the perception of personal services. The Contractor shall notify the Contracting Officer (CO) immediately if any task requires action by Contractor personnel that constitutes or is perceived to constitute personal services. These services shall not be used to execute

Government policies, make Government decisions, or manage Government personnel (i.e., inherently

Governmental functions).

1.3. Organization. The organization with primary responsibility for this requirement is the 452 AMDS.

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. The Contractor shall provide courier services for secure laboratory specimen transport. The

Contractor shall ensure that a courier service is available five (5) days a week (non-negotiable) between the hours of 8:00 a.m. and 4:00 p.m. (excluding Federal holidays) at least once a month and at a minimum twelve

(12) times a year. Collection requests are not every day and will vary based on demand. MHS Genesis integration is a plus but is not mandatory. The Contractor is not required to provide services on the following recognized Federal holidays:

• New Year’s Day

• Martin Luther King Day

• Presidents’ Day

• Memorial Day

• Juneteenth Day

• 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 and test patient specimens shall be provided by the Contractor.

1.5.3. The Contractor shall process, test, and produce results concerning all received specimens in a timely manner and in compliance with the Contractor’s accrediting agency(s) and State standards or guidelines.

1.5.4. All patient results shall be maintained by the Contractor for no less than two (2) years and be made 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 the Technical POC no later than the 15th of the following month.

2. 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 and time in accordance with PWS paragraph 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 fifteen (15) minute window from the time the courier arrives at the Visitor Control Center and 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. The Contractor shall possess either on-site capabilities to process all applicable tests or can obtain the 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 for in-service training required for the use of the Contractor’s test ordering and result management system. The training will help ensure that the 452 AMDS staff can perform routine test ordering and result retrieval and/or re-transmission of test orders and results.

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

• Register new patients or look-up existing patients.

• Search and order tests.

• Print copies of laboratory reports and 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 shall be maintained by the Contractor for no less than two (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 or 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, which means the Contractor shall not need any special Government- related computer communication access or permissions.

2.5. Due to specimen stability, with some tests requiring analysis within forty-eight (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 or resolution should issues arise. The Contractor shall receive, process, test, and provide results on all submitted 452 AMDS specimens in a timely manner and according to established guidelines. The Contractor shall provide routine test results to the 452 AMDS within twenty-four (24) hours following test completion. Test procedures requiring a turnaround time longer than twenty-four (24) hours shall be identified in the Contractor’s Laboratory User’s manual (paper, electronic, or on-line). The Contractor shall contact the 452 AMDS as soon as they are made aware when a specimen needs to be recollected, and 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 the Contractor’s published Critical Values policies, shall be called immediately to the 452 AMDS laboratory or designee with a read-back verification and documentation. The 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 each Services Summary:

SS# 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. GENERAL REQUIREMENTS:

3.1. All laboratory testing staff shall comply with minimum Federal, State, and local law qualifications and 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 the 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 Qualifications, Licensors, and Certifications (as applicable). The Contractor shall provide written verification (and photocopies where necessary) showing required certification(s), accreditation(s), license(s), etc. and these shall be furnished to the 452 AMDS/SGP via the Contracting

Officer within three (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 the contract can only be approved or authorized by the Contracting Officer.

3.4. The Contractor shall provide a point of contact (POC) who shall be responsible for the performance of the 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 Contracting Officer within two (2) days of contract award.

3.5. Quality Control. The basic quality management system shall provide for the appropriate controls of the service characteristics and attributes during performance and include inspection and test, criteria, methodology, or data that is used to verify or 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 Contracting Officer or laboratory POC a listing of external proficiency surveys through which the laboratory participated in accordance with CLIA. Survey results and statistical reviews for specific laboratory specialties shall be provided to the Contracting Officer 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 Officer, 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 and Government Inspection. The Contracting Officer’s Representative (COR) assigned to the 452 AMDS will evaluate and record the Contractor’s performance for this requirement monthly. The 452 AMDS COR will record all surveillance observations (positive and negative) within a

Performance Assessment Report (PAR). If the PAR indicates deficiencies in the performance of the contract when assessed against each Service Summary threshold, the COR will then provide the monthly PAR to the

Contracting Officer, who will in turn notify the Contractor’s POC of the deficient performance and negative assessment. The Contractor POC will then need to address the PAR deficiencies and all actions to be undertaken by the Contractor to remedy the negative performance.

3.7. Reference Manual. The Contractor shall provide a hardcopy reference manual or 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 the HIPAA Privacy & Security Rule and shall be held accountable for compliance with health information privacy and security policies and procedures (Reference HIPAA of 1996 for detailed language).

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