Attachment 1 Performance Work Statement and QASP.pdf

U.S. Department of Agriculture (USDA)

Performance Work Statement and QASP

Occupational Medical Surveillance Program

Peoria IL

General Information

1.0 Background and Purpose: USDA ARS NCAUR Occupational Medical Surveillance

Program. The OMSP is provided to authorized employees considered for assignment or presently assigned to work with chemical, biological, and/or physical hazards and is established and administered by the USDA ARS Policy 414.0 “ARS Occupational Medical Surveillance

Program.” The OMSP is designed for the detection of occupationally significant medical anomalies. With limited exceptions, participation in the OMSP is voluntary. As such, participants are allowed to refuse any procedure they chose. The limited medical procedures performed are not intended, and should not be construed, to substitute for the care provided by the employee’s personal physician (Exhibit C).

2.0 Scope: The Prime Contractor shall provide Occupational Medical Surveillance Program

(OMSP) services to NCAUR employees as specified in this Statement of Work. The contractor shall be responsible for furnishing personnel, materials, equipment, facilities, and otherwise accomplish all things necessary for or incidental to the performance of the work set forth therein.

This is a performance-based requirement, the labor mix of employees to perform this contract remains the discretion of the Contractor for all services.

3.0 Definitions:

3.1 CLIN – Contract Line Item, numbered. Established in the solicitation schedule, will start with “0001.”

3.2 Privity of Contract - Contract service providers shall be accountable solely to the Prime

Contractor, who, in turn, is responsible to the Government.

3.3 Program Office Administrative Officer – USDA Employee Location/Program Office administrative representative identified by the Contracting Officer at point of award. The

Program Office Administrative Officer may not be physically located at the facility.

3.4 IDIQ – Indefinite Delivery Indefinite Quantity. The contract clauses govern administration.

3.5 Program Year – The year period that corresponds to an IDIQ Option Year.

3.6 ‘Calendar Days’- Every single day on the calendar (12 AM to 11:59 PM), including weekends, holidays, and non-working days.

3.7 ‘Business Days’ – Standard business days 8AM to 5PM USA Central Time with holiday exceptions as noted:

Listed below are official Government holidays:

New Year’s Day January 1*

Martin L. King Birthday Third Monday in January

President's Day Third Monday in February

Memorial Day Last Monday in May

Juneteenth As Indicated

Independence Day July 4*

Labor Day First Monday in September

Columbus Day Second Monday in October

Veterans Day November 11*

Thanksgiving Day Fourth Thursday in November

Christmas Day December 25*

OR when the USDA-ARS facility is closed due to local or national emergencies, administrative closings, or similar Government-directed facility closings

*In accordance with Federal regulations, if these holidays fall on a Saturday, the holiday will be observed on Friday, if Sunday, holiday will be observed on Monday.

4.0 Period of Performance: The period of performance (PoP) of the IDIQ contract shall be for one (1) Base Year of 12 months and one 12-month option year.

5.0 Hours of Service Performance: 8AM through 4 PM Central Time on Business Days, Monday through Friday.

6.0 Place of Performance:

6.1 The procedures and examinations should be conducted at the Contractor’s facility which must be within 15 miles distance from the NCAUR, 1815 N UNIVERSITY STREET

PEORIA IL 61604

6.2 The Contractor may conduct some aspects of the test procedures at the NCAUR “on site collection” should this be agreed upon as a more efficient process for the Government, participants, and the Contractor. Space at NCAUR would be made available for this purpose.

This on-site visitation may be limited to once per 12-month period.

7.0 Government Provided: The physical examination forms and patient history forms are provided by the Government and all information shall be entered on these forms. Examples of applicable forms see (Exhibit A).

8.0 Invoicing and Payment:

8.1 The "Submit Invoice-to" address for USDA orders is the Department of Treasury's Invoice

Processing Platform (IPP).

8.2 All invoices shall be submitted via the electronic Invoice Processing Platform. This is a mandatory requirement initiated by the U.S. Department of Treasury. More information is available at https://www.ipp.gov. The Department of Treasury is the point of contact for all IPP

Collector account inquiries.

8.3 Payment is in arrears pursuant to the clause at FAR 52.212-4. Note FAR 52.212-4 (i)(1)

Items accepted. Payment shall be made for items accepted by the Government that have been delivered to the delivery destinations set forth in this contract.

8.4 Payment will not be made for service in advance of delivery.

8.5 Invoicing shall be on a monthly basis.

8.6 Advance invoice approval is not required, as required approval tiers exist in IPP.

Contractor Requirements

9.0 Technical Requirements/Tasks

The following specifications are set up to provide maximum flexibility in tailoring the OMSP for each participant according to their specific workplace exposures (Exhibit B – Historical

Exposure). The Contractor shall assign a cost to the functions performed in each section. Each participant shall receive the following basic program. Table 1.0 is provided to show maximum and minimum participation and the required “Forms” discussed below are provided as Exhibit A.

9.1 General:

9.1.1 For new participants, a “Baseline Medical Surveillance Exam” begins with a review of the ARS-182 C2 “Initial Medical History Form” and includes a Physical Exam, General

Laboratory Test, Audiogram, Chest X-ray, and Pulmonary Function Test.

9.1.2 For return participants, a fasting lab test and a physical exam are required. Other tests and immunizations should be done based on exposures entered onto the ARS-182-AB form

“Participation Option and Exposure List” or at the Government’s requirement/discretion.

9.1.3 The Contractor’s physician must also review the ARS-182 C2 “Updated Medical History

Form” for the basic physical examination and document the results of the physical exam on the

ARS-182 D “Physical Exam Form”.

9.2 Physical Examination: Administration of the NCAUR Occupational Medical Surveillance

Program shall be under the supervision of a licensed Doctor of Medicine (MD or Doctor of

Osteopathy (DO)). In addition, at a minimum, the MD/DO should be Board Certified in

Occupational Medicine or Board Certified in Internal Medicine with experience, training, and/or interest in occupational health. As part of the physical examination, laboratory, and medical occupational examination results will be discussed with the participant. The physician will note irregularities and abnormalities which would jeopardize the health status of the participant via the performance of the normal work duties. Life threatening anomalous conditions will be reported expeditiously and directly to the participant and the participant’s personal physician.

9.3 General Laboratory Tests: Each Participant shall receive annual laboratory screening including blood chemistry, hematology, and urinalysis. Each of these laboratory operations shall include (but not be limited to) the following parameters:

9.3.1 Blood Chemistry: Glucose, BUN, creatinine, sodium, potassium, chloride, uric acid, calcium, phosphorous, cholesterol, triglycerides, total protein, albumin, globulin, AIG Ratio, alkaline phosphatase, lactic hydrogenase (LOH), total bilirubin (direct and indirect), serum glutamic pyruvic transaminase (SGPT) and SGPT Total, serum glutamic oxaloacetic transaminase (SOOT). An alanine aminotransferase (ALT) test may be substituted for the

SGPT test.

9.3.2 Hematology (Complete Blood Count:) Red cell count, red cell indices (MCV, MeH, MCHC), hemoglobin and hematocrit, reticulocyte count, platelet count, white cell count, and differential.

9.3.3 Urinalysis: Specific gravity, pH, microscopic examination, protein-albumin, glucose, ketones, and occult blood (optional – indicate if this will be included or not).

9.3.4 Reticulocyte (red blood count being produced in the bone marrow:) For participants working with radio isotopes or X-ray machines and/or diffraction equipment.

9.4 Other Tests: Based upon the participant’s occupational exposure record, referred to as an

ARS 182AB, the following tests shall be provided by the examining physician. Additional tests may be recommended by the examining physician and performed with prior approval from the

Government.

9.4.1 Pulmonary Lung Function (Spirometry)

The Contractor shall demonstrate the capability to provide measurements of participant lung function and capacity. Test methods shall comply with Occupational Safety and Health

Administration (OSHA) requirements and results shall be interpreted and reported by qualified personnel. Tests to be performed and parameters to be measured include:

9.4.1.1 Forced Vital Capacity (FVC)

9.4.1.2 Forced Expiratory Volume Timed for One Second (FEVI)

9.4.1.3 Ration of FEVI/FVC

Participants requiring respiratory protection for their job function must have a medical evaluation and release stating their ability to wear respiratory protective equipment. The

Contractor shall provide examinations and written certification as specified by OSHA in 29

CFR 1910.132 and 134 and provide NCAUR with the Respiratory Usability Certification

(Exhibit A - FOH-22 OSHA Respirator Medical Evaluation Questionnaire).

9.4.2 Respirator Fit Test - Qualitative fit tests shall be provided for those participants that exclusively utilize N95 disposable respirators for work related hazards as described in the

182AB. Quantitative fit testing shall be performed for those participants that are required to utilize full or partial face masks.

Respirator Use clearance and fit tests may be provided as standalone service for some participants.

9.4.3 Audiometric Examination: The Contractor shall provide a sound shielded facility in which any loss of hearing may be determined for each ear. Each ear shall be tested at the frequencies of 500, 1000, 2000, 3000, 4000, 6000, and 8000 HZ. International Standards

Organization (ISO) standards apply. Hearing loss shall be identified and categorized as to probable cause.

9.4.4 Chest X-ray: Initial baseline and as needed when determined by the examining physician, the Contractor shall provide a full-size chest X-ray of the participant. X-rays will be used judiciously and all Illinois State and Federal regulations pertaining to leakage, scatterings, and procedures will be strictly adhered to. Films will be interpreted by board certified radiologists.

Those participants occupationally exposed to asbestos containing material as specified in current OSHA Standards (29 CFR 1910 and 29 CFR 1926 as applicable) shall be X-rayed as noted above, except that “B” reader techniques shall be used and the films will be read by a board-certified radiologist qualified as a “B” reader.

9.4.5 Specific Cancer Screening Tests: We believe that there are three applicable laboratory screening procedures for detection of a limited number of types of cancer in large populations.

These tests are the PAP smear (for women), sputum cytology, and urinary sediment cytology.

The PAP smear is not within the scope or intention of this program; therefore, the Contractor shall provide the two latter procedures for participants who have been designated eligible.

Specimens shall be carefully processed, and slides shall be examined and interpreted by experienced, certified pathologists. The Contractor may provide suggestions and rationale for the inclusion of additional screening procedures in this section.

9.4.6 Cholinesterase Determination: Several approved methods for the determination of cholinesterase levels in serum and in RBCs exist. The Contractor shall justify the choice of a particular laboratory method and adhere to it throughout the course of this contract. Regardless of the particular analytical techniques selected, the Contractor shall perform cholinesterase testing for both serum and RBC cholinesterase levels. The determination of only serum cholinesterase levels is unacceptable. Results and normal comparative values shall be reported uniformly and accurately for each cholinesterase determination.

9.4.7 EKG Testing: When so directed, the Contractor shall provide the participant 12 Lead

EKG testing.

9.4.8 Additional Tests: Additional tests other than the screening procedures listed above may be required or warranted. The Contractor is invited to recommend additional requirements and shall have the capability to perform screening tests prescribed. Additional screening tests may be directed by the Federal Occupational Health (FOH) physician and are not within the scope of this contract.

9.5 Screening Analysis and Communications: The results of all tests and physical examinations (Completed ARS-182D) are to be evaluated by the Contractor’s physician, professional staff, and Reviewing Medical Officer (RMO). They shall determine if the participant has detectable medical problems, and if so, to what extent they may possibly be work-related. Those abnormal parameters identified as being occupationally related or are likely to be aggravated by continued similar occupational exposure, will be brought to the attention of the appropriate Government personnel (OMSP Coordinator or Program Office Administrative

Officer). Prior medical history and exam results, when available, may be used to assist in making determinations.

The RMO shall prepare and send a confidential letter, mailed directly to each participant’s mailing address within 30 days. This letter documents all medical problems detected (Medical

Disposition Report), in addition to identifying specific anomalies deemed to be potentially work-related. The RMO shall prepare a second letter, mailed directly to the OMSP Coordinator, that only documents work-related abnormalities when found (Medical Disposition). Respirator

Medical Clearance certificates shall be sent directly to the OMSP Coordinator. No other medical information other than work-related abnormalities should be sent to the participant’s workplace. The Contractor RMO may provide advice and consultation services to participants and to local management officials.

9.6 Post Incident Exposure Monitoring: Should an NCAUR OMSP participant experience an accident or incident of elevated exposure to workplace hazards, the Contractor may be requested to provide post-incident exposure monitoring services. This is not within the scope of this contract and would require Government approval.

9.7 Scheduling:

9.7.1 The Government will provide the Contractor with a list of names of employees and tests required at least a month prior to the desired examination date. The Government will have their participants contact the Contractor directly and negotiate their appointment time.

9.7.2 When possible, aggregate appointments for onsite lab draws may be coordinated with the

Government for improved efficiency and participant time commitment.

9.7.3 Appointment times shall be between 8:00AM and 4:00PM, ‘Business Days’ Monday through Friday.

9.8 Reporting:

9.8.1 All required examination forms shall be completed.

9.8.2 The Contractor shall maintain all data and records securely for potential forwarding to the

Government Occupational Health Physician (DHHS, Division of Federal Occupational Health) within 30 calendar days of a written request. Records shall be maintained for year-over-year trend analysis. Rules and guidelines for maintaining medically sensitive records shall follow all applicable federal state and local regulations. Participants shall have full access to their own medical records through written request or by voluntary participation in electronic charting/records as administered by the Contractor. Any potential work-related illness or injuries shall be submitted, in writing, to the Program Office Administrative Officer for review

(see section 9.5).

9.8.3 A summary shall be prepared every 90 days, due via email to the Program Office

Administrative Officer within 10 calendar days of end of each 90-day period. Details required:

9.8.3.1 Name(s) of participant(s) tested

9.8.3.2 Work Location(s) of participant(s) tested

9.8.3.3 Date of test(s)

9.8.3.4 Type of test(s) performed

9.9 Deliverables Schedule:

Item

No.

Deliverable Objective Due

Examination

Appointments

The Government will provide the Contractor with a list of names of participants and tests required at least one month prior to the desired examination date. The Government will have their participants contact the Contractor directly and negotiate their appointment time.

As coordinated with NCAUR officials.

Screening

Analysis &

Reporting

The results of all tests are to be reported to and evaluated by the Contractor's physician and professional staff. Further tests may be permitted as deemed necessary by the physician with Governments official prior approval.

Within 30 calendar days of the date of the examination.

3 Medical Review

All required examination forms shall be completed. The results of all tests are to be evaluated by the Contractor's physician (MD/DO Board Certified Occupational Medicine or Internal Medicine) and professional staff. Those abnormal parameters identified as being occupationally related or are likely to be aggravated by continued similar occupational exposure, will be brought to the attention of the Program

Office Administrative Officer.

Within 30 calendar days of the date of the examination.

4 Records

Any potential work-related illness or injuries shall be submitted, in writing, to the Program Office Administrative

Officer for review. All required examination forms shall be securely maintained for year over year trend analysis.

As coordinated with NCAUR officials.

10.0 Contractor Personnel

10.1 Contractor Key Personnel: The Prime Contractor shall provide Administration of the medical surveillance services under the supervision of a licensed Doctor of Medicine (MD) or

Doctor of Osteopathy (DO). In addition, at a minimum, the MD/DO should be Board Certified in Occupational Medicine or Board Certified in Internal Medicine with experience, training and/or interest in occupational health. This individual or individuals are also designated as the

Reviewing Medical Officer (RMO) in this document.

10.2 Privity of Contract:

10.2.1 Contract service providers shall be accountable solely to the Prime Contractor, who, in turn, is responsible to the Government.

10.2.2 The USDA is not responsible for Prime Contractor personnel actions, such as hiring evaluations, position interviews, resume reviews, contacting individual contractor employees, etc.

11.0 Security Requirements

11.1 On site collection:

11.1.1 In the event of an on-site collection, a copy of an official government photo ID (State issued driver’s license or ID card, passport, green card, etc.) must be provided to the Program

Office administrator no later than one week before arrival of contract service technician(s) except in the case of an emergency service, were only the name of the technician will be provided via email or telephone.

11.1.2 Security access to the NCAUR will be under visitor status. As such, the following criteria will be followed:

11.1.2.1 A V badge is required for those accessing the building.

11.1.2.2 Visits by non-U.S. citizens must be approved by the Program Office Administrative

Officer.

11.1.2.3 Visitors must check in at the lobby and present a valid photo ID and vehicle license plate number.

11.1.2.4 Visitors must always be physically escorted by an NCAUR employee.

11.2 Medical Data Security: All medical records generated will be maintained in a classified data handling system, administered in such a way as to ensure confidentiality. Only the

Government Safety and Health Program Staff, (DHHS included) and the Contractor’s physician and medical staff shall have access to the results of the medical screening. Copies of all medical screening results will be provided to the participant and/or the participant’s physician of choice upon receipt of a formal written request.

12.0 Table 1.0 – Maximum and Minimum Participants in a Program Year

The cumulative minimum number of participants in a Program Year is 40 and maximum is 120 participants. Itemized estimates below:

Service Minimum Number of

Participants

Maximum Number of

Participants

Physical Exam 40 120

General Lab Tests 40 120

Pulmonary Function Test 25 100

Respirator Usability Certificate 20 60

Audiometric Testing 15 40

Chest X-Ray 1 5

EKG 1 5

Cholinesterase Testing 1 5

Onsite General Laboratory

Tests 40 120

Quality Assurance Surveillance Plan

13.0 Performance Requirement Measures/QASP:

The Government shall establish a Quality Assurance Surveillance Plan (QASP) as a means of evaluating whether the Contractor is meeting the performance standards/quality levels identified in the PWS to ensure that the government pays only for the level of services received. The requirements are stated below.

Tasks Standards Acceptable Quality

Level (AQL)

Contractor Performance

Requirements and Tasks identified in Sections 8, 9, 10, 11, 12

Standards as established in

Contractor Performance

Requirements and Tasks in

Section 8, 9, 10, 11, 12

100%

14.0 Exhibits A, B, and C: