PWS Darby contract Project.pdf

PWS

PERFORMANCE WORK STATEMENT

OCCUPATIONAL MEDICAL EXAMINATIONS AND EVALUATIONS

LOCAL NATIONAL EMPLOYEES IN DARBY, ITALY (USAG)

TABLE OF CONTENTS

SECTION TITLE

C-1 General/Scope of Work

C-2 Definitions

C-3 Government Furnished Services

C-4 Contractor Furnished Items/Services

C-5 Specific Tasks

C-6 Applicable Regulations, Manuals, Technical Documents, Specifications, and Forms

C-7 Quality Management

C-8 Sexual Assault Prevention and Response Program (SHARP)

C-9 Health Insurance Portability and Accountability Act (HIPAA)

C-10 Exclusion from Participation in Federal Health Care Programs (October 2015)

Technical Exhibits Summary

Technical Exhibit 1 Italian Legislative Decree Law 81/2008, November 2020

Technical Exhibit 2 Condition of Employment (COE), November 2018

Technical Exhibit 3 Authorized Government personnel

Technical Exhibit 4 Examinations Monthly Level of effort (LOE)

Technical Exhibit 5 U.S. Installation Pass Requirements

Technical Exhibit 6 Performance Requirements Summary (PRS)

Technical Exhibit 7 U.S. Army Livorno Facilities

SECTION C-1

1. GENERAL

This is a non-personal services contract. The Contractor shall provide certified and credentialed Occupational Health Physician(s) (Medico Competente), medical examination facilities, management and supervision, administration, personnel, transportation, tools, equipment and materials to execute Local National (LN) Employees Occupational Health Services in accordance with the Italian Legislative Decree 81/2008 (Testo Unico sulla Salute e Sicurezza sul Lavoro, D.lgs. 9 Aprile 2008, n. 81 e s.m.i.), revision November 2020 (Technical Exhibit #1), to include all future amendments and supplements, as well as Conditions of Employment for Local National Employees of the U.S. Armed Forces in Italy (COE) effective 1 November 2018, to include all future updates and revisions (Technical

Exhibit #2).

1.1. SCOPE OF WORK: The Contractor shall perform preventive, scheduled occupational medical surveillance examinations and other special occupational medical evaluations of designated Darby Livorno Local National (LN) employees of the U.S. Armed Forces in Italy, in accordance with this Performance Work Statement (PWS) and the estimated monthly Level of Effort (LOE) in Technical Exhibit #4.

1.1.1. Occupational Health Surveillance examinations consist of initial pre-employment, periodic, termination, and ongoing examinations as outlined in Article 41 Sorveglianza Sanitaria, to include all related amendments and supplements, of Italian Legislative Decree 81/2008 (Testo Unico sulla Salute e Sicurezza sul Lavoro, D.lgs. 9 Aprile 2008, n.

81).

1.1.2. The Contractor assumes full accountability for responsibilities and obligations of the Employer's (U.S. Army) compliance with applicable Local National Employee Occupational Health Services Italian Legislative Decree 81/2008 (Testo Unico sulla Salute e Sicurezza sul Lavoro, D.lgs. 9 Aprile 2008, n. 81), to include future revisions and updates.

1.1.3. The Contractor’s Occupational Health Physician (OHP) (Medico Competente) shall perform Risk Assessments of LN employees’ worksites and activities in coordination with U.S. Government personnel to include, at a minimum, the Responsible for Services of Prevention and Protection (RSPP/ASPP) (Addetti e Responsabili del servizio di prevenzione e protezione dai rischi).

1.1.3.1. The Contractor’s OHP (Medico Competente) shall participate and perform Risk Assessments and evaluations of LN employees’ worksites at a minimum once a year or at different frequency depending on the risk assessment evaluations, in accordance with Article 25 (Obblighi del medico competente) of the Italian Legislativ Decree 81/2008 (Testo Unico sulla Salute e Sicurezza sul Lavoro, D.lgs. 9 Aprile 2008, n. 81).

1.1.3.2. ALLEGATO 3B art 40. The Contractor’s OHP (Medico Competente) shall submit, no later than 31 March of the calendar year, to the Italian Safety agency the information through the form called allegato 3B in accordance with Article 40 (Rapporti del medico competente con il Servizio Sanitario Nazionale) medico competente) of the Italian Legislative Decree 81/2008 (Testo Unico sulla Salute e Sicurezza sul Lavoro, D.lgs. 9 Aprile 2008, n. 81).

1.1.4. The Contractor shall utilize a certified and accredited Laboratory for the performance of all laboratory examinations. The external Laboratory performing examinations shall be, at a minimum, accredited by the “Bureau Veritas Certification” or equivalent entity, and shall hold, at a minimum, a “Quality in Laboratory Medicine ISO 9001:2008 certificate (Qualità in medicina di Laboratorio, certificato ISO 9001:2008).

1.1.4.1. Laboratory results shall be made available in the Physician Statements “Giudizio d’Idoneità alla mansione specifica” within one (1) working day from the visit.

1.1.4.2. The Contractor shall notify within one working day the Contracting Officer Representative (COR) identified in Technical Exhibit #3, when results from additional examinations cannot be delivered within the timetable described in § 1.1.4.1.

1.2. ADMINISTRATION:

1.2.1. The Contractor shall provide sufficient organizational resources and management controls to ensure that this task is performed efficiently, accurately, on time, and in compliance with the requirements of this PWS and all Applicable Laws and Regulations,

1.2.2. The Contractor shall designate in writing a single Program Manager (PM) to oversee and supervise staff assigned to the performance of this contract. The name of this person, and an alternate or alternates, who shall act for the Contractor when the manager is absent, shall be designated in writing to the Contracting Officer. Both the PM and the alternate shall be able to converse in English and the host nation language to the degree that they understand oral and written communications and express themselves in matters pertaining to their duty.

1.2.2.1. The PM or alternate shall have full authority to act for the Contractor on all contract matters relating to the operation of this contract.

1.2.3. The Contractor shall designate an Occupational Health Surveillance Physician (Medico Competente), accountable for coordination, interpretation and implementation of current and forthcoming Occupational Health Services requirements in the Italian and Toscana Region territory.

1.2.3.1. The Contractor shall designate and sustain, throughout the entire contract period, an Occupational Health Surveillance Physician (Medico Competente) with, at minimum, three (3) uninterrupted years of experience in organizations with 500 or more employees.

1.2.3.2. The PM, its Alternate and the Occupational Health Surveillance Physician (Medico Competente) designation letters shall be provided to the Contracting Officer prior to the contract start date. The Contractor shall notify the Contracting Officer of any changes, in writing, within one workday of the change.

1.2.4. Communication: The Contractor’s OHP (Medico Competente) shall meet periodically with the designated U.S. Army RSPP and the Contracting Officer Representative (COR) and/or Technical Representative of the Contracting Officer (TRCO), identified in Technical Exhibit #3, to discuss compliance with Servizio Prevenzione Igiene Sicurezza Ambienti di Lavoro (SPISAL) directives and policies, to address problem areas and to track contract compliance by all parties or as agreed upon by all parties.

1.2.4.1. The COR and/or TRCO will provide an agenda to attendees within one week of the scheduled meeting. The meeting site and time will be confirmed with the agenda. Meetings will be conducted at the Darby Livorno Occupational Health Offices (OHO) in Caserma Darby.

1.2.4.2. Participants in the periodic meetings are, at a minimum: Employer (USAG Vicenza Garrison Commander and/or his Deputy), the Contractor’s OHP (Medico Competente), the RSPP and Workers Safety Representatives (RLS Rappresentanti dei Lavoratori per la Sicurezza).

1.2.4.3. Participants to the periodic meetings may extend, among others, from representatives of: USARAF/SETAF Office of the Staff Judge Advocate; Civilian Personnel Advisory Center; Fire Department and Radiation Safety Officers.

1.2.4.4. Technical Exhibit # 3 is a living document, and the Authorized Government Personnel may be changed by the Government and the Contractor as necessary. Technical Exhibit # 3 revisions, signed by the COR and the Contractor, shall be submitted to the Contracting Officer for Final Approval within five (5) workdays upon concurrence of the changes.

1.2.5. Language: The Contractor shall provide during the performance of services under this contract, at least one individual who is able to read, write, speak, and understand Italian and English. Without prejudice to the obligation to provide all documentation in

English for contractual purposes, all documents, reports, or communications required by law for the Italian authorities must be produced in Italian according to the required official formats. An English translation of such documents must be provided to the COR.

1.3. KEY PERSONNEL:

1.3.1. The Contractor shall utilize for the performance of this contract only qualified physicians, fully licensed to practice medicine in Italy, with steady current credentials in Occupational Health Surveillance (Medico Competente) in accordance with Article 38 (Titoli e requisiti del medico competente) of the Legislative Decree 81/2008.

1.3.1.1. The PM or its Alternate shall submit copies of licenses and credentials to the Contracting Office, for the Contractor’s OHP (Medico Competente) utilized for the performance on this contract.

1.3.1.2. The Contractor’s OHP (Medico Competente) shall be registered and maintain registration in the Italy National List of OHPs (Elenco nazionale dei medici competenti) for the entire duration of the contract period of performance.

1.3.1.3. The Contractor’s OHP (Medico Competente) shall maintain license and credentials in accordance with Article 38 (3) of the Legislative Decree 81/2008 (art. 38 comma 3 D.lgs.

81/2008).

1.3.2. The Contractor shall utilize, for the performance of laboratory examinations, only qualified, credentialed healthcare personnel, physicians and/or nurses.

1.3.2.1. The Contractor shall submit copies of licenses and credentials of healthcare personnel, physicians and/or nurses who will be dedicated to the performance of laboratory examination, to the Contracting Office.

1.3.3. Management of Key Personnel: The selection, assignment, reassignment, transfer, supervision, management, and control of Contractor key personnel in the performance of this contract, shall be the sole responsibility of the Contractor.

1.3.4. The Contractor shall comply with the general intent and specific policies set forth in this PWS and the relevant U.S. and Italian Laws and regulations referenced in § 1. of this

PWS

1.3.5. Sexual Harassment/Assault Response and Prevention (SHARP). The contractor shall comply with OTSG/MEDCOM Policy Memo 20-047, Sexual Harassment/Assault Response and Prevention Program, 28 August 2020, or superseding DHA or DOD policy once issued and provided to the contractor. The SHARP reporting requirements apply only to knowledge obtained by contractor personnel while performing services under this contract.

1.3.5.1. The contractor shall require all CSPs with knowledge of an incident of sexual assault occurring on a Government facility, to include a Government leased facility, where the contractor is providing services under this contract, to report the incident to the contractor who shall immediately (within 24 hours, after gaining knowledge) report the incident in writing to the Government's COR. This reporting policy also applies to sexual assault incidents involving MEDCOM personnel that occur on the contractor’s owned or leased facility under this contract. All incidents shall be reported whether they involve contractor personnel or Government personnel, or other individuals, when the incidents occur on a Government facility or a Government leased facility.

1.4. SECURITY REQUIREMENTS:

1.4.1. Contractor’s personnel may be granted access to U.S. Army worksites and installations for official business, with the appropriate coordination of the Darby Livorno Occupational Health Offices (OHO.

1.4.2. Access and General Protection/Security Policy and Procedures: Contractor and all associated sub-Contractors’ personnel (if any) shall comply with applicable installation, facility and area commander installation/facility access and local security policies and procedures (provided by the COR and/or TRCO). The Contractor shall also 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.

1.4.2.1. Contractor personnel shall comply with all personal identity verification requirements as directed by DOD, 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) at any individual facility or installation change, the Government may require changes in Contractor security matters or processes.

1.4.2.2. The Contractor must obtain clearance from the COR and/or TRCO pursuant to the Installation Pass requirements for contractors outlined in AR Army Regulation 190-16 entitled Installation Access Control and may be viewed at https://aepubs.army.mil/pdfpubs/AER190-16.pdf . An excerpt from this regulation is provided in Technical Exhibit #5.

1.4.2.3. Physical Security. The Contractor shall be responsible for safeguarding all Government equipment, information and property provided for Contractor use in accordance with Attachment # 1 (LRMC Memorandum 190-5 Security management).

NOTE: Due to the size of Attachment # 1, it is provided as separate file during solicitation and at award.

1.4.2.4. All Contractor personnel shall meet local site requirements for Base Access. All non-US Contractor personnel shall meet any Garrison or USAREUR required AT/Operations Security training and requirements as well as local host country background investigations.

1.4.2.5. Standard. Contractor personnel shall observe and comply with all rules, policies, and regulations prescribed by the installation Command and other federal authorities concerning eating and smoking areas, fire, safety, sanitation, security and possession of firearms or other lethal weapons.

1.4.2.6. Contractor personnel entering the Government installation shall abide by all security regulations for the installation which may be in effect during the contract period and shall be subject to such checks as may be deemed necessary to ensure that no violations occur. No employee will be permitted on the installation when such checks reveal that his/her presence would be detrimental to the security of the installation.

1.5. MEDICAL RECORDS AND PRIVACY LAW COMPLIANCE:

1.5.1. The Contractor shall process and store all data necessary for the fulfillment of the contract’s performance and for the maintaining of all accountability records in protected data processing systems in accordance with Italian Data Protection Authority (DPA) Laws, (Garante per la Protezione dei Dati Personali) as well as Health Insurance Portability and Accountability Act (HIPAA).

1.5.2. The Contractor obligates its physicians and ancillary staff to maintain strict confidentiality in accordance with Italian Laws and Regulations as well as HIPAA.

1.5.3. The Contractor shall deliver to the employer, at the termination of the employment, the medical records in accordance with Article 25 (d) Italian Legislative Decree 81/2008 (Testo Unico sulla Salute e Sicurezza sul Lavoro, D.lgs. 9 Aprile 2008, n. 81).

1.5.4. The Contractor shall deliver to the employee, at the termination of the employment, a copy of the medical record and risk assessment in accordance with Article 25 (e) Italian Legislative Decree 81/2008 (Testo Unico sulla Salute e Sicurezza sul Lavoro, D.lgs. 9 Aprile 2008, n. 81).

1.5.5. ALLEGATO 3B art 40. The Contractor’s OHP (Medico Competente) shall submit, no later than 31 March of the calendar year, to the Italian Safety agency the information through the form called allegato 3B in accordance with Article 40 (Rapporti del medico competente con il Servizio Sanitario Nazionale) medico competente) of the Italian

Legislative Decree 81/2008 (Testo Unico sulla Salute e Sicurezza sul Lavoro, D.lgs. 9 Aprile 2008, n. 81).

1.6. QUALITY CONTROL:

1.6.1. In compliance with the contract clause FAR 52.246 entitled "Inspection of Services- Fixed Price", the Contractor shall provide a Quality Control Plan that contains, at a minimum, the items listed in § C-1, C-3 and C-5 to the COR and Contracting Officer for acceptance not later than 10 days of the start of the contract. The Contracting Officer will notify the Contractor of acceptance or required modifications to the plan before the contract start date. The Contractor shall make appropriate modifications and obtain acceptance of the plan by the Contracting Officer.

1.6.2 The plan shall include:

1.6.2.1. A description of the inspection system to cover all services listed on the Performance Requirements Summary (PRS) listed in Technical Exhibit #6. Description shall include specifics as to the tasks to be inspected on both a scheduled and unscheduled basis, frequency of inspections, and the title and organizational placement of the inspectors.

1.6.2.2. A description of the methods to be used for identifying and preventing defects in the quality of service performed.

1.6.2.3. A description of the records to be kept to document inspections and corrective or preventive actions taken.

1.6.3. The records of inspections shall be kept and made available to the Government throughout the contract performance period and for the period after contract completion until final settlement of any claims under this contract.

1.7. HOURS OF OPERATION:

1.7.1. Contractor’s Program Manager and his/her alternate who shall be responsible for receiving service calls from the COR and/or TRCO, shall be available five (5) days a week from 0800 until 1700 each day. In case he/she is not reachable by phone, the Contractor shall take measures to ensure a call back to the COR and/or TRCO, within one (1) hour.

1.7.2. The Contractor shall provide the required services during the normal workweek hours Monday through Friday, exclusive of Italian holidays, U.S. Federal Holidays and officially conceded “bridge days “.

1.7.2.1. The Contractor shall designate, at a minimum, one (1) and/or two (2) days per week to accommodate Health Surveillance Examinations, Tests and Analysis requests.

1.7.2.2. The Contractor is not entitled to cost reimbursement for unused appointment slots for designated days and/or U.S. Army officially conceded days off duty due to official security measures. The OHO and the COR will promptly inform the Contractor Task manager(s) of examinations cancellations and re-scheduling plans.

1.7.2.3. The Contractor shall be available for scheduling appointments every Monday- Friday (except on Italian Holidays, as listed below) from 0800-1200 hrs at a telephone number provided by the Contractor to OHO and the COR. The following are recognized U.S.

Federal and Italian holidays:

U.S. Federal Holidays

1st January New Year’s Day

3rd Monday in January Martin Luther King Day

3rd Monday in February Washington’s Birthday

Last Monday in May Memorial Day

4th July Independence Day

1st Monday in September Labor Day

2nd Monday in October Columbus Day

11th November Veteran’s Day

Thursday November Thanksgivings Day

25th December Christmas Day

Italian Holidays

1 January New Year's Day

6 January Day of Epiphany

25 April Liberation Day

1 May Labor Day

2 June Republic Day

15 August Assumption Day

1 Tuesday in November All Saints' Day National Unity Day

8 December Immaculate Conception

25 December Christmas Day

26 December Saint Stephen's Day

1.7.3. EMERGENCY SERVICES: Services may be required to support an activation or exercise of contingency plans outside the normal duty hours described above. The Contractor's responsibilities for emergency support are specified in Section C-5, § 5.1.2.2.

1.8. PLACE OF PERFORMANCE

1.8.1. Place of Performance shall be the Contractor’s Examination Facility identified and listed by the Contractor in Technical Exhibit #7 in response to the mandated requirements of the solicitation.

SECTION C-2 DEFINITIONS

2. STANDARD DEFINITIONS:

2.1. Acceptable Quality Level (AQL). AQL is the maximum allowable percentage of deviation from perfect performance for an individual service output.

2.2. Contracting Officer (KO). The individual with the authority to enter into, administer, and/or terminate contracts. The KO is the exclusive Government official authorized to execute changes and authorize deviations or variations from the contract.

2.3. Contract Officer’s Representatives (COR): Administrative/technical representative assigned to Public Health Command-Europe (PHC-E) responsible for assisting in administration of the Government’s quality assurance portion of the contract. This person is designated in writing by the KO to be responsible for quality assurance, inspection, surveillance documentation and monthly acceptance of Contractor’s performance. A copy of the letter of designation will be provided to the Contractor.

2.4. Technical Representative of the Contracting Officer (TRCO): Administrative/technical representative assigned to Public Health Command-Europe (PHC-E) responsible for assisting the COR in administration of the Government’s quality assurance portion of the contract. This person is designated in writing by the KO to be responsible for quality assurance, inspection, surveillance documentation and monthly acceptance of Contractor’s performance. A copy of the letter of designation will be provided to the Contractor.

2.5. Occupational Medical Surveillance Examination: Preventive or periodic health examination IAW host nation standards performed to anticipate any disease before it occurs and avoid pathological consequence. This is anpreventive activity and not a diagnostic evaluation.

2.6. Performance of Work Statement (PWS): Scope and definition of occupational medical services provided under the contract.

2.7. Quality Assurance: Those actions taken by the Government to assure services meet the requirements of PWS.

2.8. Quality Control: Those actions taken by a Contractor to control the performance of services so that they meet the requirements of the PWS.

2.9. TECHNICAL DEFINITIONS PECULIAR TO THIS PWS:

2.9.1. Fitness for Duty evaluation, Fitness for Duty Examination: (Idoneità sanitaria per la mansione specifica). Objective assessment to determine if a current employee is or cannot perform essential job functions with particular emphasis on identification of characteristics that are associated with increased risk of harm to self or others.

2.9.2. Personal Protective Equipment (PPE): This includes, but is not limited to, gloves, aprons, goggles, respirators, clothing, hearing protection and other articles intended to protect the worker from exposure to various hazards of the workplace.

2.9.3. Occupational Health Offices (OHO): All activities whose requirements for occupational medical evaluations will be ordered under this contract.

2.9.4. Employee Health Database (EHD): This form is generated digitally, and it is used to document employee demographic and worksite hazard information for coordinating occupational health services from the Contractor.

NOTE: The Contractor provides the EHD digital form to the COR and/or TRCO, at the end of each day after examinations have occurred.

2.9.5. Physician Statement: This is the “Giudizio d’Idoneità alla mansione specifica” which the Contractor completes after the employee has been evaluated. The Physician Statement “Giudizio d’Idoneità alla mansione specifica” details the outcome of the services provided and any recommended follow-up.

2.9.6. Occupational Medical Surveillance Examination. Preventive or periodic health examination, in accordance with host nation. The objective of this monitoring is to anticipate any disease before it occurs and avoid pathological consequences. This is a preventive activity and not a diagnostic evaluation. Frequency is based on host nation standards and determined by the occupational medicine physician.

2.9.7. ASPP (Addetti del Servizio di Prevenzione e Protezione). Designated Personnel to Prevention and Protection Services, in accordance with Articles 31, 32 and 33 of the Italian Legislative Decree 81/2008 (Testo Unico sulla Salute e Sicurezza sul Lavoro, D.lgs. 9 Aprile 2008, n. 81).

2.9.8. RSPP (Responsabile del Servizio di Prevenzione e Protezione). Responsible for Prevention and Protection Services in accordance with Articles 31, 32 and 33 of the Italian Legislative Decree 81/2008 (Testo Unico sulla Salute e Sicurezza sul Lavoro, D.lgs. 9 Aprile 2008, n. 81).

2.9.9. Occupational Health Physician (Medico Competente). Licensed and Credentialed Physicians specialized in Labor and Occupational Health Services in accordance with Articles 38 of the Italian Legislative Decree 81/2008 (Testo Unico sulla Salute e Sicurezza sul Lavoro, D.lgs. 9 Aprile 2008, n. 81).

2.9.10. SPISAL (Servizio Prevenzione Igiene Sicurezza Ambienti di Lavoro). The Service managing prevention of accidents and diseases and work-related through vigilance, care and promotion of health and safety in the workplace.

2.9.11. RLS (rappresentanti dei lavoratori per la sicurezza). Workers Safety representatives.

SECTION C-3

GOVERNMENT FURNISHED SERVICES

3. GENERAL: The Government will provide the Contractor with the services listed below at no cost.

3.1. WORKSITE EVALUATIONS:

3.1.1. General Worksite Risk Assessments and Evaluations: The U.S. Army personnel will facilitate and coordinate local LN worksites visits for Risk Assessment and Evaluations. The ASPP/RSPP, COR and TRCO, are recognized as the people responsible for coordinating all worksites visits. Worksite visits will be conducted on an average of four (4) per month with the expected time for completion of one hour.

3.1.2. Worksite Hazard Evaluations: The U.S. Army personnel will facilitate and coordinate local LN hazardous worksites visits for Risk Assessment and Evaluations. The ASPP/RSPP, the COR and the TRCO, are recognized as the people responsible for coordinating all hazardous worksites visits.

3.1.3. Worksite Risk Assessment and Evaluation visits must be coordinated through COR and/or TRCO, and ASPP/RSPP not later than 60 days prior to the visit. Complete worksite visit reports must be provided to the OHO and ASPP/RSPP within five (5) working days from the date of the visit.

3.1.4. The contractor shall ensure all service providers receive Sexual Harassment/Assault Response and Prevention (SHARP) training not later than 60 calendar days after contractor personnel begin performance under this contract. Training can be obtained either online or in person. Contractor personnel can attend SHARP training provided by MEDCOM on every other month basis by contacting (210) 221-6118 for class date/ time availability. If the employee has an AKO account, they can access online the Team Bound Self Study course through Army Learning Management System (ALMS) at http://www.atsc.army.mil/tadlp/delivery/alms.asp

SECTION C-4

CONTRACTOR FURNISHED ITEMS AND SERVICES

4. GENERAL: Except for those services specifically stated to be U.S. Army furnished in Section C-3, the Contractor shall furnish and maintain all equipment, supplies, records and all other items necessary to perform all services outlined in this PWS.

4.1. EXAMINATION FACILITIES: The Contractor shall perform all examinations at its facilities, within maximum twenty-five (25) kilometers of the U.S. Army Camp Darby. The Contractor’s examination facilities shall be suitable for the specific examinations and provide privacy for the examinee.

4.1.1. The Contractor's facilities shall be credentialed as ambulatory care clinic (studio medico o ambulatorio). The ambulatory care clinic shall comprise, at a minimum, a staffed dedicated reception desk, as well as distinct areas/ rooms, dedicated solely to laboratory tests and screenings (hearing, vision, PFT).

4.1.1.1. The ambulatory rooms dedicated to examinations and diagnostics shall comprise, at a minimum, of an Examination table; an Integrated Diagnostic System; Examination lights; ECG devices; a Spirometer; a Personal computer for patient information entries; a Storage cabinetry; a Sink and a counter.

4.1.1.2. The ambulatory rooms dedicated to hearing examinations shall be conformed to standards ISO 8253-1:2010 or ANSI S3.6-1996, conducive to noise reduction.

4.1.1.3. Vision screening examinations shall be performed with the support of Vision Screeners. Examinations with Eye charts may be performed temporarily yet conformed to the guidelines of the Eye Chart manufacturer.

4.1.2. The ambulatory care clinic should have separate bathrooms for public use. The ambulatory care clinic shall include a bathroom, away from the waiting room area, dedicated solely to drug tests.

4.1.2.1. During drug tests procedure, employees may choose that the observer be of their same gender. The Contractor shall make available responsible chaperones of the requested gender, upon employees’ request.

4.1.3. Contractor’s Occupational Health Physician (OHP) and all healthcare personnel dedicated to the examinations and lab tests should wear medical apparel, to always include identification name tags with titles.

4.1.4. All examinations shall be performed using calibrated equipment conformed to manufacturer operational standards. The ambulatory care clinic shall have the capability to make examinations and tests results available to employees on site, in printed format.

4.1.5. The Contractor's facilities shall be visible to pedestrians and motorists by a signpost on the building. The Contractor's facilities shall offer, at a minimum, three (3) dedicated parking spaces, within one hundred meters from the facilities.

4.2. The Contractor is not authorized to provide occupational health services in any U.S.

Army building or facility.

Note: Exception is made for unannounced, random Alcohol testing described in §5.4.12.

4.3. Re-Referrals: The Contractor is to fully provide all required examinations on its premises. Specialty examinations not offered at the Contractor site may be outsourced to medical facilities within maximum 10 kilometers of the Contractor’s site.

4.3.1. The Contractor shall coordinate Specialty examinations and/or care with the local - OHO and COR, prior to scheduling of Re-referrals.

4.4. Reporting: The Contractor’s OHP (Medico Competente) shall provide to the Contractor Task Manager(s) worksite visit reports and any applicable worksite personal or site monitoring results for inclusion in the affected employee’s medical records, to facilitate appropriate performance of the scheduled medical examinations.

SECTION C-5 SPECIFIC TASKS

5. SPECIFIC TASKS: This section specifies details as to the scope of work to be performed under the contract:

5.1. The Contractor shall provide Occupational and Environmental Health Surveillance Services to the Darby Livorno Local National (LN) employees of the U.S. Armed Forces in Italy, except for Local Nationals employed by AAFES. The Contractor shall provide specialized Occupational Health Surveillance expertise and support to Local National employees.

5.1.1. The Contractor shall organize and perform Occupational Health Surveillance in accordance with the Italian Legislative Decree 81/2008 (Testo Unico sulla Salute e Sicurezza sul Lavoro, D.lgs. 9 Aprile 2008, n. 81 e s.m.i.), revision November 2020, to include all future amendments and supplements.

5.1.2. The Contractor shall guarantee the performance of Occupational Health Surveillance and Examinations in accordance with Article 41 (Sorveglianza Sanitaria) of the Italian Legislative Decree 81/2008 (Testo Unico sulla Salute e Sicurezza sul Lavoro, D.lgs. 9 Aprile 2008, n. 81 e s.m.i.), revision November 2020, to include all future amendments and supplements. Here below a summary excerpt from Article 41:

a. Preventive Health Examination aimed at proving the absence of counter-indications to the task that the worker will have to perform to evaluate his or her suitability to the specified task.

b. Periodic Health Examinations to verify employees' health suitability for specific tasks.

c. Health Examinations at employees' request.

d. Health Examinations when changing duty position, to verify the suitability in the specific tasks.

e. Health Examinations upon termination of employment.

f. Pre-Placement Health Examinations.

f.1. The Contractor shall, in accordance with U.S. Army employment directives, provide a summary of health suitability (sommario di Giudizio d’idoneità) in Pre-Placement form OPF 178 July 2009 (Attachment # 2).

g. Health Examinations after a period exceeding sixty consecutive sick leave days in order to verify fitness duty in the specific tasks.

5.1.2.1. The Contractor’s OHP (Medico Competente) shall be available to conduct Health Examinations, at a minimum, for five (5) days per calendar month.

5.1.2.2. Flexible Dates. The Contractor’s OHP (Medico Competente) shall be available to conduct Health Examinations during emergency circumstances (i.e. Pre-Placement actions § 5.1.2 (f), Sick Leave § 5.1.2 (g).

5.1.2.3. The Contractor’s OHP (Medico Competente) shall have the capability to perform, at a minimum, up to twenty (20) Health Examinations per day, to include all laboratory tests and screenings required for each employeein accordance with the OHO schedule of appointments, in accordance with estimated LOE in Technical Exhibit #4.

5.1.2.4. The OHO, in coordination with the COR and/or TRCO will forward updated schedules of appointments to the Contractor on a quarterly basis.

5.1.2.4.1. The OHO, in coordination with the COR and/or TRCO will confirm 24 hours prior to the Health Examination date, the list of scheduled employees to include the types of testing as described in § 5.4 of this PWS.

5.1.2.5. The Contractor shall provide to the-OHO the list of availability dates for each month, at a minimum, sixty (60) days before the beginning of the month.

5.1.3. The Contractor’s OHP (Medico Competente) shall provide individual counseling and information to LN employees with specific reference to their area of responsibilities. (i.e.

workplace hazards, use of Personal Protective Equipment (PPE).

5.1.4. The Contractor’s OHP (Medico Competente) shall perform Risk Assessments of LN employees’ worksites in coordination with U.S. Army Government personnel to include, at a minimum, the Representatives of Prevention and Protection Service, RSPP/ASPP, (Addetti e Responsabili del servizio di prevenzione e protezione dai rischi).

5.1.4.1. The Contractor’s OHP (Medico Competente) shall participate and perform Risk Assessments and evaluations of LN employees’ worksites at a minimum once a year or at different frequency depending on the risk assessment evaluations, in accordance with Article 25 (Obblighi del medico competente) of the Italian Legislative Decree 81/2008 (Testo Unico sulla Salute e Sicurezza sul Lavoro, D.lgs. 9 Aprile 2008, n. 81), as well as in accordance with SPISAL directives and regulations (Servizio Prevenzione, Igiene e Sicurezza negli Ambienti di Lavoro).

5.1.4.2. The Contractor’s OHP (Medico Competente) shall submit Worksite Visit Reports in the English language to the COR or TRCO, to the ASPP/RSPP, and to the PHC-E Occupational Health Nurse Consultant, no later than 5 calendar days after worksite visits.

5.2. REPORTING OF EXAMINATION RESULTS

5.2.1. The Contractor shall submit a Daily Report, electronically, to OHO within one (1) business day after employees have been examined. The Daily Report shall include, at a minimum, employees’ name, type of examination performed and types of laboratory test(s) and screening(s).

5.2.2. The Contractor shall submit an electronic Monthly Report to-OHO within five (5) working days of month end, detailing the number of Occupational Health Examinations, to include numbers and dates of examinations and tests performed and completed.

5.2.3. The Contractor shall transmit copies of the Physician Statements “Giudizio d’Idoneità alla mansion specifica” in the Italian and in the English language, in PDF format, within one (1) working day from the visit, to:

a) the Civilian Personnel Office; b) the Employee; c) the OHO.

5.2.3.1. The Contractor shall utilize a door-to-door traceable shipment method using the commercial addresses listed in Technical Exhibit # 3.

5.2.3.2. The Contractor shall mail medical records or documents covered under privacy laws, by labeling them ‘confidential’, packaged, sealed and mailed with the package contents to arrive intact.

5.2.3.3. For examinations requiring testing for which results cannot be expected within one

(1) working day from the visit, the Contractor shall notify the OHO, within one (1) business day of the timetable for expected results.

5.2.4. The Contractor shall submit the aggregate annual report indicating, at a minimum, Occupational Health summary results, frequency and Risk Assessments in accordance with Article 25 (Obblighi del medico competente) of the Italian Legislative Decree 81/2008 (Testo Unico sulla Salute e Sicurezza sul Lavoro, D.lgs. 9 Aprile 2008, n. 81).

5.2.5. The Contractor shall update and maintain employees’ medical records (Cartella Sanitaria), in accordance with Article 25 (Obblighi del medico competente), of the Italian Legislative Decree 81/2008 (Testo Unico sulla Salute e Sicurezza sul Lavoro, D.lgs. 9 Aprile 2008, n. 81).

5.2.5.1. The Contractor shall process, store and maintain safeguard employees’ data and medical records (Cartella Sanitaria), in a secure environment, in accordance with Italian Data Protection Authority (DPA) Laws, (Garante per la Protezione dei Dati Personali) as well as Health Insurance Portability and Accountability Act (HIPAA), as referred in § 1.5.1 of this

PWS.

5.2.6. The Contractor shall promptly report to the appropriate Italian authorities, (SPISAL, INAIL, ISPESL, etc.) cases of occupational illnesses discovered during employees’ examinations.

5.2.7. The Contractor shall, simultaneously, inform the U.S. Government personnel, the - OHO, the COR, and/or Technical Representative of the Contract Officer, the ASPP/RSPP and the Civilian Personnel Office, of the submission in § 5.2.6. of cases of occupational illnesses discovered during employees’ examinations.

5.3. MEETINGS/CONFERENCES

5.3.1. The Contractor’s OHP (Medico Competente) shall attend annual meetings in accordance with article 35 (Riunione periodica) of the Italian Legislative Decree 81/2008 (Testo Unico sulla Salute e Sicurezza sul Lavoro, D.lgs. 9 Aprile 2008, n. 81).

5.3.2. The Contractor’s OHP (Medico Competente) shall attend, at a minimum, three (3) periodic meetings to review Risk Assessments, update the database, and update the health surveillance protocol (Protocollo Sanitario), in coordination with the ASPP//RSPP, the Civilian Personnel Office Representative, and -OHO personnel

5.3.3. The Contractor’s OHP (Medico Competente) shall participate in the development of Risk Assessment Document meetings in accordance with article 29 Modalities for performing the evaluation of risks (Modalità di effettuazione della valutazione dei rischi) of the Italian Legislative Decree 81/2008 (Testo Unico sulla Salute e Sicurezza sul Lavoro, D.lgs. 9 Aprile 2008, n. 81).

5.4. WORK SITE VISITS

5.4.1. Contractor shall conduct work site visits as described in paragraph 3.1.1. of the

PWS.

5.5. EXAMINATIONS / TESTS

5.5.1. LNs HEALTH EXAMINATIONS

5.5.1.1. Contractor shall provide Health Examinations as described in paragraph 5.1.2. of the PWS. Contractor shall provide Health Examinations as described in paragraph 5.1.2.

The examination shall include filling out medical record as per annex 3A following law changes, vital signs, spinal examination and upper limb when it is requested by the type of work and the lifting required by the job.

5.5.2. EKG (Electrocardiogram Test)

5.5.2.1. The Contractor shall perform EKG in accordance with employees’ worksite, duty position and established Risk Assessments reports.

5.5.2.2. The Contractor may forward EKG reports, in coordination with the COR, to a Cardiologist for the evaluation of the results. Cardiologist shall return results to the Contractor for determination of the employee's fitness for duty.

5.5.3. VISION SCREENING

5.5.3.1. The Contractor shall perform vision screening in accordance with employee’s worksite, duty position and established Risk Assessments reports.

5.5.4. AUDIOGRAMS

5.5.4.1. The Contractor shall perform Audiograms in accordance with employee’s worksite, duty position and established Risk Assessments reports.

5.5.5. PULMONARY FUNCTION TESTING (PFT)

5.5.5.1. The Contractor shall perform PFT testing in accordance with employees’ workplace, duty position and established Risk Assessments reports.

5.5.6. SPECIALIST EXAMINATION AND CERTIFICATION

5.5.6.1. The Contractor shall refer employees to a specialist to complete more extensive testing and evaluation not available at the Contractor’s facility. Unit price to include testing and evaluation performed by Specialist.

5.5.7. BLOOD LAB ANTIBODY TITERS

5.5.7.1. The Contractor shall conduct blood antibody titer tests in accordance with employee’s worksite, duty position and established Risk Assessments reports.

a) Hepatitis B Titer: Performed as a one-time test on employees who require proof of Hepatitis B immunity.

b) Hepatitis C Titer (HCV): Performed as a one-time test on employees who require proof of Hepatitis C immunity

c) Varicella Titer: Performed as a one-time test on employees who require proof of Varicella immunity.

d) MMR Titer: Performed as a one-time test on employees who require proof of MMR immunity.

5.5.8. CHEMISTRY 6

5.5.8.1. Chemistry 6 includes the following: CBC/Diff; Lipoprotein Panel; GGT; Urea Nitrogen/Creatinine; Hepatic Function Panel; Glucose Fasting.

5.5.8.2. The Contractor shall conduct Chemistry 6 tests in accordance with employees’ worksite, duty position and established Risk Assessments report.

5.5.8.3. Chemistry 6 shall be conducted in coordination with scheduled appointments prepared by the Darby Military Community-OHO personnel and COR

5.5.9. URINALYSIS (UA)

5.5.9.1. The Contractor shall conduct Urinalysis (UA) tests in accordance with employees’ worksite, duty position and established Risk Assessments reports.

5.5.10. METAL SCREENING

5.5.10.1. Metal Screening includes the following: Hippuric Acid (Urine); Methyl-Hippuric Acid (Urine); Alau-Delta Aminolevulinic Acid (Urine); ZPP-Zinc Protoporphyrin (Blood); Lead (Blood)

5.5.11. BLOOD COLLECTION

5.5.11.1. The Contractor shall conduct Blood Collection in accordance with employees’ worksite, duty position and established Risk assessment reports.

5.5.12. DRUG TESTING

5.5.12.1. The Contractor shall conduct Drug Testing in accordance with Italian Legislative Decree 81/2008 (Testo Unico sulla Salute e Sicurezza sul Lavoro, D.lgs. 9 Aprile 2008, n.

81), Toscana Regional and local procedures directives and laws.

5.5.12.2. The Contractor shall conduct drug testing randomly in accordance with employees’ worksite, duty position and established Risk Assessments reports.

5.5.12.3. Drug Testing shall be conducted in coordination with scheduled appointments prepared by OHO personnel, COR and ASPP/RSPP, during the periodic visits, during the fitness for duty physical, upon return to work after a positive test, and/or after an on-the-job injury.

5.5.12.4. The Contractor shall submit urine samples to a certified laboratory when the drug tests performed are positive.

5.5.12.5. Laboratory Referral (Positive Drug testing). The Contractor shall immediately forward a Positive resulting test to a specialized health facility for the execution of a second level assessment.

5.5.13. ALCOHOL TESTING

5.5.13.1. The Contractor shall conduct Alcohol Testing in accordance with Italian Legislative Decree 81/2008 (Testo Unico sulla Salute e Sicurezza sul Lavoro, D.lgs. 9 Aprile 2008, n. 81), Toscana Regional and local procedures directives and laws.

5.5.13.2. The Contractor shall conduct alcohol testing, breathalyzer, randomly in accordance with employees’ worksite, duty position and established Risk Assessments reports, in coordination with the -OHO personnel, COR and ASPP/RSPP.

5.5.13.3. Alcohol Testing may be also conducted in conjunction with the medical examination. Positive results will be reported to CPAC POC and follow up will be conducted IAW with Italian Legislative Decree 81/2008 (Testo Unico sulla Salute e Sicurezza sul Lavoro, D.lgs. 9 Aprile 2008, n. 81), Toscana Regional and local procedures directives and laws.

5.5.14. ENTOMOLOGIST SCREENING

5.5.14.1. Entomolitist Screening includes the following: Total Protein (Serum) Electrophoresis and RBC Cholinesterase.

5.5.15. HIV.

5.5.15.1. The Contractor shall conduct HIV Testing in accordance with Italian Legislative Decree 81/2008 (Testo Unico sulla Salute e Sicurezza sul Lavoro, D.lgs. 9 Aprile 2008, n.

81), Toscana Regional and local procedures directives and laws.

SECTION C-6

APPLICABLE REGULATIONS, MANUALS, TECHNICAL DOCUMENTS, SPECIFICATIONS, AND

FORMS

6.1. LIST OF APPLICABLE PUBLICATIONS - ITALY:

a. Technical Arrangement between the Ministry of Defense of the Italian Republic and the Department of Defense of the United States of America regarding the installations / infrastructure in use by the US Forces in Italy, 16 April

2008 para VIII (2).

b. Decreto Legislativo 9 aprile 2008 n. 81 – Testo unico sulla salute e sicurezza sul Lavoro e s.m.i.

LIST OF APPLICABLE PUBLICATIONS – U.S.:

c. 29 CFR 1910 Occupational Safety and Health Standards, General Industry, last updated 28 Feb 2006 http://www.osha.gov/pls/oshaweb/owastand.display_standard_group?p_toc_level=1&p_p art_number=1910

d. 29 CFR 1910.1020 Access to Employee Exposure and Medical Records.

http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id= 10027

e. AR 40-5, Preventive Medicine 25 May 2007., 1-7, d. Occupational Health.

http://www.army.mil/usapa/epubs/pdf/r40_5.pdf

f. AR 40-66, Medical Record Administration and Healthcare Documentation, 4 January http://www.army.mil/usapa/epubs/pdf/r40_66.pdf

g. AR 40-562, Immunizations and Chemoprophylaxis, 29 September 2006 http://www.army.mil/usapa/epubs/pdf/r40_562.pdf

h. DA Pam 40-11, Preventive Medicine, 19 October 2009, Chapter 5, Occupational Health http://www.army.mil/usapa/epubs/pdf/p40_11.pdf

USAPHC, PHRE requires English translation of applicable Contractor unique Italian publications that affect the implementation of this contract.

SECTION C-7

QUALITY MANAGEMENT

7.1 QUALITY CONTROL. In compliance with the contract clause FAR 52.246 entitled "Inspection of Services-

Fixed Price", the Contractor is responsible for the development, implementing and maintaining of its own Quality Control Plan (QCP) to ensure that the requirements of this contract are performed in accordance with this PWS. The Contractor’s QCP is the means by which the Contractor assures that his work complies with the requirement of the contract and procedures to identify, prevent, and ensure non-recurrence of defective services are implemented.

7.1.1 The Contractor shall provide a QCP that contains, as a minimum, the items listed in C-1, C-3. and C-5., to the COR and Contracting Officer for acceptance not later than 10 days of the start of the contract. The Contracting Officer will notify the Contractor of acceptance or required modifications to the plan before the contract start date.

The Contractor shall make appropriate modifications and obtain acceptance of the plan by the Contracting Officer.

7.1.2 The plan shall include, at a minimum, a description of the inspection system to cover all services listed on the Performance Requirements Summary (PRS) listed in Technical Exhibit #6. Description shall include specific details as to the areas to be inspected on both a scheduled and unscheduled basis, frequency of inspections, and the title and organizational placement of the inspectors.

7.1.3 The records of inspections shall be kept and made available to the Government throughout the contract performance period and for the period after contract completion until final settlement of any claims under this contract.

7.1.4 Methods of communication with the U.S. Army regarding performance of the contract. The communications shall include verbal, written and electronic communication and formal meetings with U.S. Army agencies and personnel. Electronic communication regarding examinees must safeguard privacy and be in conformance with confidentiality laws.

7.1.5 The QCP shall address corrective action. The Contractor shall respond promptly and affirmatively to deficiencies discovered in the performance of this contract The Contractor shall identify and correct problem areas.

Corrective actions shall not depend on Government direction. Records shall be kept of any deficiencies discovered and corrective action taken. Short-term remedial actions and long-term solutions shall be described. A summary report of this will be forwarded to the COR. If medical information is involved, the report will be forwarded instead to the occupational medicine physician at PHC.

7.1.6 The Contractor QCP shall include a customer complaint program. This program must describe how commanders, employees, or other interested parties may identify problem areas and situations to the Contractor. The customer complaint system shall be compatible with the reporting and communication systems of the plan.

7.2. Contractor shall provide a QCP during the pre-performance conference. The QCP is not subject to approval by the Government. The COR or other Government representative may offer suggestions of items for inclusion in the QCP, but any such suggestions are strictly advisory and not mandatory. However, the Contractor shall request Contracting Officer’s acceptance in writing of any proposed change to his QC system.

7.3.