Contractor Safety Manual - Pfizer



Pfizer Lincoln Administrative Site Requirements and Practices for Contract Firms

1 Introduction 4

2 Acronyms and Definitions 5

2.1 Acronyms 5

2.2 Definitions 5

3 General Information 7

3.1 Contacts 7

3.2 Incident Reporting Procedure 7

3.3 Vehicle Permits and Access Error! Bookmark not defined.

3.4 Site Access 8

3.4.1 General Information 8

3.4.2 Active Pharmaceutical Ingredients Building Specific Access Requirements Error! Bookmark not defined.

3.4.3 Area Specific Gowning Requirements 9

3.5 Contractor Badging 9

3.5.1 New Contractor On-boarding process 9

3.5.2 Pfoenix Information 10

3.5.3 Existing Contractor Off-boarding Process 11

3.5.4 Existing Contractor Badge Renewal 11

3.5 Special Circumstance Visitor Policy 12

3.5.1 Introduction 12

3.5.2 Definitions Error! Bookmark not defined.

3.5.3 Procedure 13

3.6 Substance Abuse and Alcohol 15

3.6.1 Policy Scope 15

3.6.2 Drug Testing Guidelines 15

3.6.3 Basis for the Policy 16

3.7 Work Rules 22

3.7.1 Equipment 22

3.7.2 Smoking Policy 23

3.7.3 Dress Code 23

3.7.4 Weapons and Firearms 24

3.7.5 Cameras and Video Recorders 24

3.7.6 Beepers, Cell Phones, or Personal Electronic Devices 24

3.7.7 Prohibited Activities 24

3.8 Use of Cafeterias 25

3.9 Internal Documents and Confidentiality 25

4 Security 26

4.1 General: 26

4.2 Pfizer Engineering or Security: 26

4.3 Contractors: 26

4.4 Independent Consultants 27

4.5 Construction Site Security: 27

5 Safety 28

5.1 Emergency Numbers 28

5.2 General Guidelines 28

5.3 Fire Response Procedures 29

5.4 Four Categories of Fire 30

5.5 How to Use a Fire Extinguisher 31

5.6 Tornado Sheltering Procedures 32

5.7 Injury/Medical Response Procedures 33

5.8 Security 34

5.9 Building Emergency Maps 34

5.10 Evacuation Procedures 34

5.11 Emergency Alarms 35

5.12 Emergency Response Guide 36

5.13 Safety Equipment 36

6 Criminal Background Check Policy 36

7 Contract Firm Non-Compliance Process 40

7.1 Scope 40

7.2 Purpose 40

7.3 Responsibilities 40

7.4 Procedure/Process 41

7.5 Non-compliance Notification Process 41

8 Contractor Responsibilities Regarding Subcontractors 42

Introduction

Welcome to Pfizer Lincoln. This Contractor Requirements and Practices Guide has been prepared for Contractors, their subcontractors, visitors, delivery persons, and vendors servicing the Pfizer Lincoln facilities:

Contractors shall ensure that all employees have reviewed the sections of this document that are applicable to the work they perform. This document does not relieve the Contractor of their responsibilities to comply with all applicable local, state and federal regulations, laws, ordinances, or statutes.

Pfizer seeks to engage Contractors who dedicate themselves each day to maintaining an accident-free work place. Safety is our #1 concern. There is never an acceptable reason for compromising safety.

Pharmaceutical and biological research and manufacturing operations are potentially hazardous. Throughout our site, Pfizer engages in a broad range of activities. Many of these activities involve the use of known hazardous, flammable, or toxic substances, (intermediate drug compounds, radioisotope tracers,) and a broad-range of biological materials, each with its own set of hazards and risks. Contractors must be aware that numerous hazards exist throughout our site, and that the hazards vary widely from lab bench to lab bench, from floor to floor, and from building to building.

As evidenced by the hundreds of Pfizer colleagues safely working at our site, these hazards can be effectively managed by following a few standard safety procedures. It is important to remember that whether working at an active production facility, in a research laboratory, or even an office, it is every Contractor’s responsibility to seek out and understand workplace safety precautions, and to take those actions that will allow them to work safely in their assigned work areas. Each Contractor’s individual responsibility is to exercise educated, sound judgment and use their own experience and expertise to incorporate EH&S considerations into everything they do.

Contractors shall project a professional image at all times while reporting to/visiting/working at a US Area Pfizer manufacturing sites. Lincoln Operations regularly hosts customers, guests, and Pfizer colleagues from other Pfizer sites. The site is also subject to frequent regulatory inspections, both planned and unplanned. Violation of this and other Pfizer policies could result in expulsion of individual(s) or company from the site.

Pfizer is committed to achieving full compliance with all federal, state, and local regulations, as well as Pfizer Corporate guidelines. These guidelines apply to:

• All construction and demolition contractors, and

• All site support service vendors (including: food service, janitorial, lab or production support, administrative, security, and maintenance).

These guidelines are not intended to be inclusive of all local, state, and federal laws and regulations that Contractors are obligated to comply with.

Acronyms and Definitions

a Acronyms

The following is a list of acronyms frequently used at Pfizer facilities:

EPA United States Environmental Protection Agency

FDA United States Food and Drug Administration

GMP Good Manufacturing Practices

MSDS Material Safety Data Sheet

OSHA Occupational Safety & Health Administration

PGM Pfizer Global Manufacturing

PGRD Pfizer Global Research & Development

PPE Personal Protective Equipment

PSM Process Safety Management

b Definitions

Contracting Firm - An outside firm hired by Pfizer Inc (Pfizer) to provide maintenance, construction, repair or specialty work.

Contract Employee - A person who is employed by a firm other than Pfizer, but works at a Pfizer facility on a full or part time contracted basis, e.g., security personnel.

Contractor Safety Representative - An individual assigned by the Contractor who is responsible for the Contractor’s safety program and performance. This person has the responsibility, power, and authority to stop his/her company’s work when and where unsafe activities or conditions exist. To qualify, as a Contractor Safety Representative the individual must have completed, at a minimum, an OSHA approved 10 Hour General Construction Safety Course.

Contractor’s Competent Person - As defined by OSHA, the individual who is capable of identifying existing and predictable hazards in the surroundings, or working conditions which are unsanitary, hazardous, or dangerous to employees, and who has the authorization to take prompt corrective measures to eliminate them (see 1926.32). Some standards add additional specific requirements, which must be met by the competent person.

Good Manufacturing Practices (GMP) - GMP, also known as cGMP, stands for Good Manufacturing Practice, and is a set of regulations set forth by the FDA to help ensure that various products intended for human consumption and use are safe and effective.

GMP regulations mandate a quality-related methodology to manufacturing, enabling businesses to minimize product contamination, mislabeling and other errors. This protects the consumer from purchasing a product that may be effective or even dangerous.

Most of the GMP regulations primarily address issues such as sanitation, process validation, equipment and document traceability, and personnel qualification. Failure of firms to comply with GMP regulations can result in product recall or seizure, fines and prison.[pic][pic]

Hot Work - Any work that will result in an ignition source such as welding, cutting, use of a torch, grinding, burning, or work that involves, or creates heat or sparks.

Lock Out / Tag Out - Lock Out / Tag Out is required when working on systems involving "stored energy." This includes, but is not limited to, electrically energized equipment, pressurized piping, chemical or process piping, hydraulic systems, pneumatic systems, and stored mechanical (potential) energy. Applies to any system or equipment that presents hazards to employees if a switch is thrown, valve is opened /closed, or line is broken.

Material Safety Data Sheet (MSDS) - A document provided by the producer or supplier of a material, conforming to the requirements of the Occupational Safety and Health Act, that describes the potential hazards associated with the handling or use of the material.

Pfizer Representative - The Pfizer Representative is the individual who is responsible for initiating, coordinating and/or supervising the Contractor’s activities on Pfizer premises. The term Pfizer Rep may apply to Pfizer colleagues, or to non-Pfizer contract employees hired by Pfizer to manage contracted services at Pfizer facilities.

Safe Work Plan - A written plan prepared by the contractor that highlights specific safety-related concerns related to the contracted scope of work and how they are to be addressed. The typical plan summarizes the scope, planned approaches, and relevant safety specifics to assure the safe completion of the task, operation, or project.

Site Specific Safety Orientation – A safety orientation on issues and concerns specific to the area of work given prior to the Contractor starting work in a specific area, that is provided by a hosting Pfizer Representative or Pfizer Department Representative.

Subcontractor - A Contractor or his/her employee(s), whose contract is subsidiary to a prime contract between Pfizer and a Contractor.

Vendor - A person or company that provides a product or service to Pfizer; a person from said company who provides service on a purchased piece of equipment is also considered a vendor.

Visitor - Individual who is on site for less than 5 consecutive days, has not attended a Site Orientation Training within the past year, and is escorted and supervised 100% of the time while at a Pfizer facility by a badged Contractor, or a Pfizer employee.

Workplace - an establishment, job site, or project, at one geographical location containing one or more work areas.

Work Area - a room or defined space in a workplace where hazardous chemicals are produced or used, and where employees are present.

General Information

a Contacts

Lincoln Contractor Administration

– Manager

– Contractor badges, on-boarding and off-boarding

– Training/ Administration

– Bldg 2 Safety Compliance

–Safety Compliance

– Utilities/Facilities/Outlying buildings Safety Compliance

– ESH compliance

- Farm / Outlying Building Safety Compliance

b Incident Reporting Procedure

Because any incident is potentially serious, it is Pfizer policy that all injuries be promptly reported and investigated. Contractor injuries are to be reported immediately to your supervisor and Pfizer contact in accordance with the Pfizer Contractor Injury Illness reporting procedure. Contract firms are required to complete a Lincoln Site Contractor Incident Investigation Report and submit the form to the appropriate LCA representative. The form is available on the LCA website at the following address:

and select the “Incident Report Form” from the list. Instructions for Form submission are printed on the form.

Any injury involving chemical exposures should be directed to LCA or call 2456. Any emergency medical issue, such as those issues requiring ambulance transport, should be reported first to 2456. Non-emergency injuries can be handled via the contracting company designated medical provider. If there is any doubt as to the severity of an injury ALWAYS call 2456. Contractors should not call 911 for ambulance service. All ambulance requests should go through 2456.

The following rules apply to all Contracting Firms vehicles on Pfizer Property:

• Riding in a vehicle shall be limited to a seat in the cab/passenger compartment of the vehicle. While the vehicle is in motion, personnel shall not extend any part of their bodies beyond the line of the vehicle bed, as defined by its gates, barriers or seating arrangement.

• Materials transported which extend beyond the sides or ends of the vehicle shall be properly secured and marked with a red flag. All trucks transporting materials onto Pfizer property must be loaded in a manner that will prevent the material from falling off of the vehicle onto the roadway.

• Dump trucks, trailers or waste hauling units shall not travel with loading compartments in an elevated position. Materials shall be placed on the Pfizer site only in locations approved by the Pfizer representative.

• All vehicle requiring backup signal devices shall have such installed and in proper working order.

• Clearances must be checked when moving a high load or equipment

• When inside the perimeter fence surrounding the Pfizer- Lincoln site, Contractor vehicles must be parked in authorized areas and must have the engine turned off.

• Refueling contractor vehicles or equipment must not be done in a hazardous area such as welding or other hot work areas. Onsite fuel storage tanks require secondary spill containment and must be authorized by the Pfizer representative and Pfizer ESH personnel.

• Speed limits and traffic regulations on the Pfizer Site must be observed at all times. Extra caution must be observed in high traffic areas.

• Vehicles on the Pfizer site must be in safe mechanical condition at all times. All vehicles systems such as brakes, lights, turn signals etc. must be in proper working order. Unsafe vehicles, as determined by the Pfizer representative will be removed from the site immediately at the owner’s expense.

Visitors may park in visitor-designated parking spaces only. These parking spaces are clearly marked in the lot in front of Building 1 at the Lincoln site

c Site Access

i General Information

A Site Access policy exists to provide a framework for training and orienting individuals who are unfamiliar with procedures developed to assure not only their welfare, but also the welfare of the site working population and surrounding community.

Any person entering the Lincoln location is required to receive some type of orientation. The type of orientation received will depend on the classification of the visit.

The visit classification and its associated type of orientation are as follows:

A Contractor on site for more than 5 workings days in a year, either a planned or un-planned scenario, will complete the New Contractor Site Orientation Test.

A Contractor on site for less than 5 workings days in a year will receive a Compliance Information for Visitors Brochure. If the Contractor anticipates multiple visits during a calendar year, for any reason, they must receive complete the New Contractor Site Orientation Test.

Fire, EMS or Police personnel, while performing official functions or in case of an emergency, will require no training for access to the Lincoln site.

A Routine Delivery person will receive the Site Orientation Training.

A Non-routine Delivery person will receive a Delivery Driver Safety card.

A Visitor will receive a Compliance Information for Visitors Brochure.

A Visitor who anticipates more than 5 visits during a calendar year, for any reason, will then be considered a Contractor and complete the New Contractor Site Orientation Test.

A Regulatory Agency inspector will receive a Compliance Information for Visitors Brochure.

The Orientation Tests include information on GMP issues, training on the facility’s safety practices, emergency response procedures, and hazard communications training on area chemicals, as deemed necessary by the nature and location of the visit, and Pfizer’s expectations for conducting business in a safe manner.

The New Contractor Site Orientation Test is a 30 question test The test questions are T/F and multiple choice and use the Orientation Guide for Contract Workers as reference material. Once the contractor successfully completes the New Contractor Site Orientation Test, the contractor will be issued a badge. This Orientation training is good for 1 year from the date of completion. All contractors who need site access for more than 1 year after they have completed the Site Orientation training must complete a Refresher Orientation Training Test. This is an annual requirement. The Contractor Safety Orientation Refresher test is a 20 question open book test that also covers all aspects of Site safety and GMP requirements for contractors.

The Compliance Information for Visitors Brochure is available from Security personnel at any manned Pfizer site entrance.

All Site Orientation training is provided in English only.

The badges are the property of Pfizer Plant Security and must be returned to Plant Security upon completion of the job or when the contractor no longer works at the site. Any lost badges must be reported to the Contract company representative or Pfizer Representative, who is responsible for notifying Plant Security and obtaining a new Contract Worker badge.

ii Area Specific Gowning Requirements

There are numerous areas throughout the Lincoln Site that have specific gowning requirements. The gowning requirements are clearly marked at all entry points to those areas. Questions regarding area specific gowning requirements should be referred to the Contract Administrator.

d Contractor Badging

i New Contractor On-boarding process

Prior to any contractor (as defined above) receiving a Pfizer issued access badge, the firm or individual that the contractor is employed by must be qualified according to criteria set forth by Pfizer Procurement. These criteria are considered outside the scope of this policy. A signed approved contract between the firm that is to supply contract personnel (contractor) and Pfizer must exist before a Contractor badge is issued and subsequent site access is granted.

Prior to any subcontractor (as defined above) receiving a Pfizer issued access badge, the firm or individual that is subcontracting the work to the firm(and its employees) or individuals must complete Subcontractor Qualification information to the Lincoln Contractor Management group for Subcontractor approval. Subcontractor Qualification documents are located on the Lincoln Contractor Management websites.

These contractual requirements do not apply to visitors.

ii Pfoenix Information

The Pfoenix contractor management computer system is used by Pfizer, or their designee, to facilitate on-boarding, off-boarding and asset management for the contractor workforce. Pfoenix requires input of mandatory data, regarding the contractor, by the user. The system electronically routes the request to Pfizer management for approval, notifies the requestor that management approval has been obtained. When the requestor receives an e-mail notification of contractor on-boarding finalization from LCA, the contractor may attend Site Orientation. Without contractor on-boarding finalization from LCA, a prospective/requested contractor may NOT attend Orientation training. The system also notifies Pfizer Security that the contractor has contractor on-boarding finalization from LCA. Upon successful completion of Orientation training, which consists of completing the New Contractor Site Orientation Test, Pfizer Security will issue the individual a Contractor Badge.

The Lincoln Contractor Administration (LCA) group facilitates this activity.

The sponsor can simultaneously request any assets that the contractor may require to perform their duties. Currently, Pfoenix has capabilities to enable the user to access the forms/instructions to request the following assets:

Radios

Computers

Keys

LAN ID

Lockers

Offices

Pagers

Phones

Uniforms

GMP Training

Pfoenix will allow the requestor to access forms and associated instructions that are necessary to request the required asset. For example, when the requestor clicks on the asset “Office” in the Pfoenix system, Pfoenix will take the requestor to the Pfizer e-CFR (Communications, Facilities Request) system to request that asset.

The process is now complete.

If additional unit specific or site specific training is required for the contractor to perform the duties they were contracted for, it is the responsibility of the sponsor to insure the appropriate training is obtained. Additional information regarding contractor training and training documentation can be found in Pfizer IDP #14936, Version 5, available in the WISDOM PNU-Doc1 database.

The rehiring of any previously separated former Pfizer colleague as a contractor must include notification to the requesting unit’s Human Resource generalist and their approval prior to beginning the on-boarding process. The notification and subsequent HR approval is required to insure that specifics of the Pfizer Human Resources Separation policies are addressed. The applicable Human Resources Separation policies are considered beyond the scope of this document.

iii Existing Contractor Off-boarding Process

The Pfizer Representative responsible, or contract firm responsible, for the contractor must use the Pfoenix Contractor Management system to notify the Lincoln Contractor Administration group of termination of a contractor. The Pfizer representative, or contract firm responsible, must also ensure the following assets/materials are returned in a timely manner:

Contractor ID badge

Pfizer owned keys

Pfizer owned telecommunication devices such as radios, pagers or cell phone

Pfizer owned uniforms or other garments

Pfizer LAN ID and password

The Lincoln Contractor Management group will process all returned material in accordance with Site procedures.

iv Existing Contractor Badge Renewal

A. Renewal Requirements

All Lincoln Pfizer Service Provider Contractor badges are valid for one year from date of issue.

All Lincoln Pfizer Temporary Contract Worker Contractor badges are valid for less than or equal to six months after date of issue. Valid Pfizer Contractor badge holders are required to schedule and complete an Annual Refresher Safety Orientation test during the month their badge is set to expire.

B. Renewal Procedure

Lincoln Contractor Administration will notify the Pfizer sponsor responsible for the contractor or the firm who employs the contractor, that the contractor’s badge is set to expire and the contractor needs to obtain Refresher Orientation training to maintain their site access. Refresher Orientation training is accomplished by completing the Contractor Orientation Refresher Test. It is the contractor’s responsibility to obtain Refresher Orientation testing. LCA will also inform the parties that the Annual Orientation Refresher Training for Contractors is available as a CBT. The Orientation Refresher Test is available to all contractors on walk-up workstations during normal Badge Office business hour of 8:00 am to 3:00 pm.

If the contractor’s services are no longer needed, or they have been terminated by the hiring firm, the Pfizer off boarding procedures will be initiated, and all Pfizer property in the contractor’s possession will be retrieved, according to established Pfizer procedures.

If the contractor successfully completes the Annual Refresher Orientation Refresher Test, their current badge expiration date will be electronically updated to + 1 year from date of testing. Instructions for successful completion of the test are available at each walk-up Orientation Testing workstation. The process is now complete

3.5 Special Circumstance Visitor Policy

3.5.1 Introduction

Since the Pfizer Site Access was instituted, an additional scenario for site access for non- Pfizer colleagues, has developed. Many organizations within the Pfizer division located at the Lincoln Site purchase equipment or services that also contain a Vendor Service Representative or Vendor Expert visit to the specific organization to perform “work” as part of the associated Sales, Service or Buyers Agreement.

These firms do not have a valid current Pfizer Procurement contract, and all of the compliance measures that contract signatures insure, for the “work” that is to be done. It is assumed, based on verbal requests for their site access from Pfizer colleagues, that these firms have the expertise required for a specific task, but the amount of billable time available to the firm during any calendar year is not of a significant enough value that the firms feel compelled to fulfill all of the Pfizer Procurement Vendor Prequalification requirements.

This document will provide definitions, possible scenarios, and work flows to delineate the steps which must be taken to grant site access to these individuals, when requested.

3.5.2 Definitions

Special Circumstance Visitor - A Contract Employee, as defined above, whose Site Access is requested to perform setup, troubleshooting, or consultant work as a result of a Buyer’s agreement or service contract for a purchased instrument or equipment. This may also include an individual who possess the expertise necessary to perform specialty “work” at a Pfizer facility in Lincoln. It is anticipated this individual will be on-site more than the current 5 days allowed for a Visitor badge, and will be performing work as described in the “Work Activities” section of the Lincoln Site Contractor and Visitor Access Policy, such as Hot Work, Lock Out/ Tag Out, etc. This policy will also be in effect visits that are less than five days in duration as well.

3.5.3 Procedure

When a need for equipment setup or services arises, the Pfizer requestor will complete an ARIBA E-buy Requisition form in the normal manner. The requestor must indicate in the comment field of the E-Requisition form that the request entails the use of a Service Provider, and no contract exists between the firm requested and Pfizer. This will enable expedited review by Pfizer Procurement. This requisition form is electronically submitted to Pfizer Procurement, which will check for the following, as part of the approval and PO issuance procedure (defined elsewhere):

Firm’s liability insurance coverage

Confidentiality agreement

Company Contact Name (supervisor or Company Safety Coordinator)

Upon satisfactory review of the Requisition, Pfizer Procurement will issue a Purchase Order (PO) for the purchase of the requested goods or services.

Upon receipt of the PO, the Pfizer colleague who has made the request (Requestor), will forward the approval to the Lincoln Contractor Administration group, to initiate the site access process. The Requestor must also indicate if any of the following standard Pfizer work permits are necessary to complete the requested activities:

Lock out – tag out

Confined Space entry

Hot work

Line Break Work Permits

Fire Watch activities

Energized Elect. Work Permit

The Lincoln Contractor Administration group will be responsible for review of the request to insure the request is appropriate with regard to the length of stay, time interval of visits per year, and ultimately if the scenario matched the type of visit, as defined in this document.

Upon receipt of an e-mail from the requestor, the Lincoln Contractor Administration (LCA) group will review the request and reply to the e-mail indicating the following:

1. Approval of the request, or indicate the Pfizer Badging policy is effective in the proposed scenario, and the Badge policy rules must be initiated, to allow site access.

2. Instructions that the following rules will be in effect at all times to enable access to the site:

• Instructions that this individual must be escorted at all times by a currently badged contractor or Pfizer colleague, when inside the Pfizer perimeter fence.

• Instructions that this individual must be in compliance with all applicable Pfizer Work Rules and Safety Procedures.

• Instructions that this person may not operate any Pfizer owned or leased piece of equipment under any circumstances.

• Instructions that this individual or the contractor must contact the Lincoln Contractor Management Safety Compliance group (as listed above) to complete the required Work Activity training to obtain any necessary Work Permits as listed above, with Cc: to Account Badges (Pfizer Security) indicating LCA approval of the request. Security will forward the note to the appropriate guardhouse or point of entry to notify them of the request/approval and badge issuance is approved.

3. The Requestor or their designee will meet the individual who needs site access at the appropriate point of entry and insure a Visitor badge is obtained.

4. The Requestor, or their designee, will escort the contractor to the offices of the Safety LCA Specialists. The LCA Safety Specialist will provide the appropriate training, as required, and endorse the back of the visitor badge, as follows:

• Authorized Work Activities

• Trainer’s initials

• Date of training

• Escort Name

5. The process is complete and the Requestor and their visitor may complete their activities as necessary. It is also the requestor’s or their designee responsibility to return the contractor to the original point of site entry upon completion of all activities.

3.6 Substance Abuse and Alcohol

3.6.1 Policy Scope

All contracting firms are required to ensure that their employees, independent contractors, consultants, and all individuals who work on Pfizer premises and/or Pfizer projects under their control and/or supervision, are and remain drug-free and compliant with Pfizer's drug-free workplace standards. All individuals who are independent contractors and/or consultants and are providing services exclusive of agency control are required to be and remain drug free and compliant with Pfizer’s drug free work place standards.

Contracting agencies will be required to demonstrate that individuals, who are designated to work on Pfizer premises and/or on Pfizer projects, have passed drug tests, as appropriate.

All individuals from contracting agencies that are working on Pfizer premises and/or Pfizer projects, and whose behavior raises concerns so that reasonable-suspicion testing would be considered necessary and/or appropriate, will be removed from the workplace for further evaluation. Pfizer will work with their contracting agency to the extent practicable. These individuals will not be allowed to return to work for Pfizer pending further assessment by their contracting agency, and further review and approval by designated Pfizer Medical Department personnel.

All independent contractors and consultants exclusive of agency control who are working on Pfizer premises and/or Pfizer projects, and whose behavior raises concerns so that reasonable-suspicion testing would be considered necessary and/or appropriate, will be removed from the workplace pending further evaluation. These individuals will not be allowed to return to work for Pfizer pending further assessment, and review and approval by designated Pfizer Medical Department personnel.

3.6.2 Drug Testing Guidelines

Each contracting firm must determine the following components of their individual drug-testing program:

1. Whether or not to include Random Drug Testing

2. What drug testing panel to use (e.g., 5-Panel or 10-Panel)

3. What agency will conduct the drug testing program for the contract firm*

4. If there is reasonable suspicion that a contingent worker is under the influence of drugs and/or alcohol

*Drug testing for contract firms and their employees will not be conducted at the on-site Pfizer Health & Wellness clinics.

It is the responsibility of each contracting firm to be familiar with Pfizer’s Substance Abuse Policy (attached). If a contract firm is in need of establishing a drug testing policy, or has question as to the completeness of their current policy, the Pfizer Substance Abuse Prevention Policy is a thorough example and follows the Federal Guidelines (i.e., D.O.T. regulations) for drug testing. It should be noted the attached policy makes references to Pfizer colleague assistance plans. Pfizer contractors are not eligible for any of these referenced assistance programs.

3.6.3 Basis for the Policy

Pfizer Inc ("Pfizer" or "the Company") is committed to protecting the safety, health, and well-being of its employees, customers, and all people who come into contact with its employees, workplaces, and property, and/or use its products and services.

Pfizer recognizes that drug and alcohol abuse pose a direct and significant threat to this goal, and to the goal of a productive and efficient working environment in which all employees have an opportunity to reach their full potential. Pfizer therefore is committed to ensuring a substance-abuse-free working environment for all of its employees, and underscores that commitment through implementation and enforcement of this Substance-Abuse-Prevention Policy ("Policy").

SCOPE:

This Policy applies to all employees and job applicants. Employees subject to U.S. Department of Transportation ("DOT") drug and alcohol rules must comply with both Pfizer's policy relevant to those rules and with this Policy.

Contracting agencies are required to ensure that their employees, independent contractors, and consultants, and all individuals working on Pfizer premises and/or on Pfizer projects under their control and/or supervision, are and remain drug-free and compliant with Pfizer's drug-free-workplace standards. All individuals who are independent contractors and/or consultants and are providing services exclusive of agency control are required to be and remain drug-free and compliant with Pfizer's drug-free-workplace standards.

DRUG AND ALCOHOL PROHIBITIONS:

Drug Abuse

Pfizer strictly prohibits "illicit drugs" and "illicit drug use". "Illicit drugs" includes all drugs, narcotics, and intoxicants for which possession or misuse is made illegal under federal, state, or local law. Pfizer strictly prohibits the possession, use, sale, attempted sale, conveyance, distribution, manufacture, purchase, attempted purchase, cultivation, and/or transfer of illicit drugs at any time, and in any amount or any manner.

The deliberate use of prescription medication and/or over-the-counter drugs used in a manner inconsistent with dosing directions, and in a manner which results in workplace impairment, is considered "illicit drug use". In addition, the use of prescription medication, for which the individual does not have a valid prescription, is considered "illicit drug use". The use of chemical intoxicants for other than a legitimate and therapeutic purpose is also considered "illicit drug use".

Alcohol Abuse and Misuse

Pfizer prohibits the abuse, or misuse, of alcohol while working, present on Pfizer premises (defined as all buildings, facilities, and parking areas owned or leased by Pfizer, and all places where Pfizer conducts business), or representing Pfizer in any way. Pfizer also prohibits the use of alcohol, or the possession of opened containers of alcohol, by employees operating Pfizer-provided vehicles, or operating any other vehicle while on Company business. Moreover, the use or abuse of alcohol off-the-job which impairs, to any extent, performance on-the-job, is a violation of this Policy.

Employees are prohibited from reporting to work with alcohol in their system which may result in impairment. On occasion, Pfizer may authorize the serving of alcoholic beverages at a Company function (with the specific consent of senior management). While employees are permitted to consume alcohol at work-related functions, those employees who choose to consume alcohol at such functions are expected to drink responsibly, act professionally, exercise good judgment, and refrain from becoming intoxicated or impaired.

Use of Prescription Medications

Employees who use prescription and/or over-the-counter medications which may impair that employee's ability to perform safely are responsible for notifying their designated Medical Department, or their Human Resources Representative, so that steps can be taken to minimize the safety risks posed by such use. Employees may be asked to obtain a doctor's certification that the employee can safely perform the responsibilities of his or her position. Any information Pfizer may learn about an employee's health or medicines will be treated as confidential and shared with Company personnel only on a need-to-know basis.

It is each employee's responsibility to consult with his or her health-care provider and/or to review relevant dosing instructions to determine whether the use of a medication could lead to impairment.

The Company reserves the right to transfer, reassign, and/or place on leave of absence - or to take other appropriate action - during the time any employee uses medication that may affect his or her ability to perform safely.

DISCIPLINE:

Employees in violation of this Policy will be subject to disciplinary action, up to and including termination. In appropriate circumstances, Pfizer also will notify law enforcement and cooperate with any resulting investigation and prosecution.

COLLEAGUE ASSISTANCE PROGRAM:

Pfizer encourages employees who believe they may have a problem with alcohol or drugs - legal or illegal - to seek assistance before a Company-initiated investigation of a possible Policy violation is made. The Company offers employees assistance through its Colleague Assistance Program ("CAP"). Conversations and sessions with a CAP professional will be confidential. Except as required by law, or as necessary under exigent circumstances, the CAP will not release information without an employee's signed consent. The CAP can provide information regarding the dangers and symptoms of drug and alcohol abuse, evaluate employees for drug and/or alcohol dependence, and provide referrals for employees who may benefit from appropriate rehabilitation programs that emphasize counseling and treatment.

Any request for assistance will be treated confidentially. An employee's good-faith decision to seek help voluntarily will not be used as the basis for disciplinary action against the employee. Individuals requesting voluntary assistance for a substance-abuse problem may be eligible for an approved, paid leave to pursue treatment and rehabilitation.

Please note that an employee's decision to seek assistance under this Policy will be considered voluntary only if the employee seeks assistance prior to a Company-initiated investigation of a possible Policy violation and/or prior to being asked to take a drug and/or alcohol test. Entering a drug- and/or alcohol-assistance program will not absolve or protect employees from any adverse employment action to which the employee would otherwise be subject, including for substandard work performance, and/or for other workplace policy violations.

DRUG AND ALCOHOL TESTING:

In furtherance of its goal of ensuring a substance-abuse-free workplace, Pfizer has established the following drug- and alcohol-testing program for its employees and for job applicants. Employees and job applicants covered by U.S. Department of Transportation testing regulations are subject to testing under this Policy and under the Company's DOT testing policy.

Pfizer may require employees and job applicants to submit to testing for the presence of illicit drugs or alcohol. All employee time spent engaged in the testing process will be compensable work time. Transportation to the test site will be provided for employees, or employees will be reimbursed for costs associated with travel to the collection site.

Job Applicants

All job applicants must take and pass the mandatory drug test as soon as practical following their acceptance of a conditional offer of employment, and prior to the actual time they commence employment with Pfizer. A confirmed positive test will result in the withdrawal of an offer of employment, and the applicant will not be permitted to repeat the testing process.

A job applicant's refusal to submit to drug testing, or attempt to tamper with, substitute for, adulterate, dilute, or otherwise falsify a test sample will be considered a withdrawal from the application process, and will result in denial of employment.

Employees

Pfizer employees will be subject to drug and/or alcohol testing as a condition of employment/on-going employment under the following circumstances, and as otherwise directed by the Company, at its sole discretion:

Reasonable-Suspicion Testing - Pfizer may require employees to submit to drug and/or alcohol testing whenever Company management has reason to believe that the employee is demonstrating signs of impairment due to alcohol or drugs, appears unfit for duty, or may otherwise be in violation of this Policy. Reasonable-suspicion determinations will be based on specific, contemporaneous, articulable observations concerning the appearance, behavior, speech, and/or smell of the individual. Reasonable-suspicion determinations may include, but are not limited to:

 

Observed physical symptoms or manifestations of being under the influence of drugs or alcohol while at work or on duty;

The direct observation of what appears to be drug or alcohol use while at work or on duty; and/or

A credible report of drug or alcohol use in violation of this Policy.

 

Post-Incident Testing - Pfizer may conduct post-incident testing when an employee is involved in any accident or near-accident except as restricted by law.

 

Unannounced Random Testing - All Pfizer employees, including all management employees, are subject to unannounced random drug testing, consistent with applicable laws. Employees will be selected for testing at random - using a neutral, objective selection procedure - from the pool of individuals subject to such testing.

 

Safety-Sensitive Testing - Employees who work in safety-sensitive positions also are subject to unannounced random drug and/or alcohol testing, depending upon the nature of their assignment and responsibilities, consistent with applicable laws. Employees who are subject to this requirement will be so notified at the time they are conditionally offered employment with the Company, when they are offered a transfer to a position subject to such testing, and/or when their position becomes subject to such testing. Employees will be selected for testing at random - using a neutral, objective selection procedure - from the pool of individuals subject to such testing. The Medical Director, Corporate Human Resources will notify site Human Resources where necessary, regarding job classifications subject to such testing.

 

Return-to-Work Testing - Employees who are permitted to return to work after violating this Policy, and/or who are returning to work following rehabilitation, will be required to take and pass a return-to-work drug and/or alcohol test before resuming work. 6. Follow-Up Testing - Unannounced follow-up drug and/or alcohol testing may be required as a condition of continued employment during and after an employee has participated in a treatment program for drug or alcohol abuse, and/or has tested positive for illicit drug use, for a period of up to two years, or as recommended by the individual employee's treatment provider.

Contractors, Consultants, and Temporary Employees

Contracting agencies are required to ensure that their employees, independent contractors, and consultants, and all individuals who work on Pfizer premises and/or Pfizer projects under their control and/or supervision, are and remain drug-free and compliant with Pfizer's drug-free workplace standards. Contracting agencies will be required to demonstrate that individuals, who are designated to work on Pfizer premises and/or on Pfizer projects, have passed drug tests, as appropriate.

All individuals from contracting agencies who are working on Pfizer premises and/or Pfizer projects, and whose behavior raises concerns so that reasonable-suspicion testing would be considered necessary and/or appropriate, will be removed from the workplace for further evaluation. Pfizer will work with their contracting agency to the extent practicable. These individuals will not be allowed to return to work for Pfizer pending further assessment by their contracting agency, and further review and approval by designated Pfizer Medical Department personnel.

All independent contractors and consultants exclusive of agency control who are working on Pfizer premises and/or Pfizer projects, and whose behavior raises concerns so that reasonable-suspicion testing would be considered necessary and/or appropriate, will be removed from the workplace pending further evaluation. These individuals will not be allowed to return to work for Pfizer pending further assessment, and review and approval by designated Pfizer Medical Department personnel.

POLICY VIOLATIONS:

Drug Tests

An employee whose drug test is verified positive is considered to be in violation of Company policy and will be subject to adverse employment action, up to and including termination, as allowed by law.

Alcohol Tests

A confirmed positive alcohol test showing the presence of alcohol in an employee's system, at a level which may cause impairment, may be considered proof that the employee who tested positive has violated this Policy, and will be subject to adverse employment action, up to and including termination, as allowed by law.

Observed Behavior

A credible report of an employee's use of illicit drugs or chemical intoxicants, other than in a manner and for a purpose permitted by this Policy, will be considered proof that this Policy has been violated, as may other evidence, depending upon the circumstances, independent of Pfizer's drug- and alcohol-testing program. Whenever practicable, however, testing will take priority and will be the primary basis for determining if the Company's Policy has been violated.

Convictions

An employee's conviction for a drug-related offense while employed by Pfizer will be considered a violation of this Policy.

Refusal-to-Test

An employee's refusal to submit to drug and/or alcohol testing will constitute insubordination, and will result in immediate termination. A job applicant's refusal-to-test will result in recission of a job offer letter and denial of employment. Any attempt to tamper with, substitute for, adulterate, dilute, or otherwise falsify a test sample is considered a refusal-to-test, as is a failure to complete the testing process, a failure to fully cooperate in the testing process, and/or other conduct which would intentionally prevent or compromise a valid test result.

TESTING SAFEGUARD AND PROCEDURES:

Consent

No drug or alcohol test will be administered, or sample collected, without the written consent of the employee or job applicant to be tested. However, testing is a condition of Pfizer employment, and an individual's refusal to complete a written consent form is equivalent to a refusal-to-test.

Cost of Testing

Pfizer will pay the costs of all drug and/or alcohol tests it requires of its employees and job applicants.

Collection and Chain-of-Custody

Persons being tested will be asked to provide a test sample by the collection-site person. Procedures for collection of specimens will allow for reasonable individual privacy. Urine samples will be tested for temperature and adulterants, and will be subject to other validation procedures. The collection-site person and the person being tested will adhere to chain-of-custody procedures at all times.

Testing Methods

All urine samples will be screened using an immunoassay technique and all presumptive positive tests will be confirmed using gas chromatography/mass spectrometry (GC/MS) or another equally sensitive and reliable methodology. All confirmatory tests will be performed by a laboratory certified by the federal Substance Abuse and Mental Health Services Administration ("SAMHSA") for federal workplace testing. [Pfizer currently tests for cannabinoids ("marijuana"), cocaine metabolites, amphetamines (including methamphetamines and some prescription stimulants), opiates (including codeine, morphine, heroin, methadone, meperidine, hydrocodone, hydromorphone, and oxycodone), phencyclidine ("PCP"), barbiturates, and benzodiazepines (including Valium and Xanax), and may test for other drugs, at its sole discretion, in which case, job applicants and employees will be advised of the additional substances for which Pfizer may test (This provision to be added, as required by law, in Hawaii, Iowa, Montana, and Oklahoma.)].

Typically, breath tests will be used to detect the presence of alcohol. Occasionally, oral fluid (saliva) testing or blood alcohol testing may be utilized. If breath alcohol testing is used, positive tests will be confirmed with a second breath test. Employees may request a confirmatory blood-alcohol test if they so desire.

Review of Positive Results

Any individual whose test is positive for the presence of an illicit drug or drugs will be so notified by an independent Medical Review Officer ("MRO") (a medical doctor with an expertise in toxicology), and given an opportunity to provide the MRO, in confidence, with any legitimate explanation he or she may have that would explain the positive drug test.

If the individual provides an explanation acceptable to the MRO that the positive drug-test result is due to factors other than the consumption of illicit drugs, the MRO will verify the test as negative, and so report it to the designated Pfizer Medical Department.

Notification of Positive Results

Individuals will be be notified by Pfizer's Medical Review Officer (MRO) of a positive result and will be provided with a copy of the certifying laboratory's test results when requested. In addition, an individual who tests positive for drugs may, within 72 hours of notification, ask that his or her positive urine sample be sent to an independent SAMHSA-certified laboratory for a second confirmatory test, at the individual's expense. However, the Company may suspend, transfer, or take other appropriate action regarding the individual pending the results of any such re-test.

Confidentiality

All test results will be treated as confidential, and will only be disseminated within the Company on a need-to-know basis. Test results will not be released outside the Company without the written consent of the tested individual, except as consistent with legal obligations and/or pursuant to legal proceedings. Test results forwarded by the MRO will be retained in the individual's confidential medical file, separate from his or her personnel file.

Compliance with All Applicable Laws

Pfizer will implement this Substance-Abuse-Prevention Policy, including the drug- and alcohol-testing provisions, in a manner that complies with all relevant federal, state, and local laws.

SEARCHES:

When Pfizer has a reasonable basis to believe that an employee is violating any aspect of this Policy, he or she may be asked by the Company to submit immediately to a search or inspection, which may extend to personal property, as appropriate. Such a search or inspection can be required at any time (including during breaks and the lunch period) while on Company premises, representing the Company, or at the Company's clients' locations.

An employee's refusal to consent to a search or inspection when requested by Pfizer constitutes a violation of this Policy and - as with other violations of this Policy - is grounds for adverse employment action, up to and including dismissal.

GENERAL RESPONSIBILITY:

Substance-abuse prevention is everyone's responsibility. Pfizer expects all of its employees to recognize and accept this responsibility, and to do their part in assuring that, working together, we can achieve and maintain a substance-abuse-free working environment for all Pfizer employees.

3.7 Work Rules

3.7.1 Equipment

Use of Pfizer equipment, tools or materials by contractor employees or subcontractors is strictly prohibited. If business needs require contract staff to use specialized site-specific equipment and/or facilities provided by Pfizer. Pfizer owned equipment & facilities such as material handling trucks and carts, floor washers, freight elevators, chain and electric hoists, monitoring equipment, fans and blowers etc. may be used by non-Pfizer workers when the following conditions are met:

a. A principal owner of the contracting company agrees to hold Pfizer harmless if contractor workers are injured using the equipment or facilities. (or attachment to PO / general conditions)

b. The contractor has demonstrated to the Pfizer contact person that the contractor cannot economically provide the equipment and/or facilities.

c. The contractor ensures their workers are properly trained in the safe and environmentally compliant operation of the equipment, or facilities, and that the equipment is operated in a safe and environmentally compliant manner.

d. The contractor provides training and skills testing for their employees. Pfizer personnel may train non-Pfizer worker as the last resort, if no other competent trainer is available. If this occurs, Procurement should be contacted to determine if a more qualified contractor can be obtained. If State or Federal regulations mandate a certification of training, the contractor ensures their employees who operate the equipment have the appropriate credentials. The contractor provides their Pfizer contact person with documentation of each operators training, if it is requested.

The equipment must be inspected before each use, and not used if problems are found.

Use of wood in support of construction activity is highly discouraged. If absolutely necessary, and only with the PCA’s approval, pressure treated wood may be allowed into a GMP manufacturing facility.

All problems and accidents involving the equipment are immediately reported to their Pfizer Responsible person.

3.7.2 Smoking Policy

Pfizer facilities are smoke free facilities. Exterior smoking areas have been designated on the site. Consult your Pfizer representative for the location of the designated smoking area nearest to your work area. Due to the nature of site operations, smoking outside of these designated areas creates a potential serious hazard and will not be tolerated. Violation of this policy may result in immediate removal from Pfizer premises.

3.7.3 Dress Code

Contractor clothing is to be clean and project a professional appearance at all times. Contractors shall wear appropriate, clean working attire or clothing, free of holes, tears, frays, or foreign matter. Contractor Employer provided uniforms are preferred however plain shirts are acceptable. Shirts must be tucked in at all times. Hardhats and ball caps are not to be worn backwards while inside a manufacturing building.

Contractors clothing shall provide the level of personnel protection appropriate for the task. Contractors, while performing construction work on our site, must wear ANSI approved safety (steel toe / puncture rated) and safety glasses at all times. Hardhats must be worn in designated Hardhat areas at our site.

3.7.4 Weapons and Firearms

Weapons and Firearms (including, but not limited to: nuclear / biological / chemical / incendiary / anti-personnel / or explosive devices (fire works, blasting caps, detonator cord, shaped linear charges, and other high explosives), swords, knives (excluding pocket / utility knives used for construction activities), hat pins, pikes, sabres, mauls, bats, clubs, throwing stars (and other martial arts equipment), shanks, trebuchets, mortars, cross bows, long bows, sabots, hand guns, long guns, blow guns, dart guns, air guns, machine guns, paint ball guns, multiple launch rocket systems, mechanized armour, and poison frogs) are prohibited at all times from Pfizer premises.

3.7.5 Cameras and Video Recorders

Use of cameras, video recorders, tape recorders, and other audio-visual equipment by contractors without written authorization from the Pfizer Facilities Manager, Pfizer Security, and Pfizer Corporate Communications, is prohibited.

3.7.6 Beepers, Cell Phones, or Personal Electronic Devices

Pagers and cell phones for business purposes may be allowed with the prior approval by the Pfizer responsible, on a case-by-case basis. Only UL listed, intrinsically safe cell phones and pagers that are rated for use in hazardous locations (a.k.a. explosion proof) are allowed in production and warehousing areas.

Personal electronic devices, such as: Personal Digital Assistants (PDA’s – a.k.a. Palm Pilots), portable CD/ DVD/ MP3 players, or similar devices are prohibited from all production and warehousing areas, where they represent a potential ignition source due to their non-explosion proof design.

3.7.7 Prohibited Activities

Any contractor may be removed from the premises immediately, and their employer informed, when there is reasonable cause to believe that gross misconduct has been committed, during the course off work being performed on Pfizer property.

These activities include but are not limited to the following:

Insubordination

Theft

Dishonesty

Time reporting fraud

Disclosure or inappropriate use of confidential information

Negligence

Fighting or other disruptive behavior

Gambling

Possession of weapons, firearms, ammunition or incendiary devices

Inappropriate possession, consumption, sale, or use of alcohol

Inappropriate possession, consumption, sale, or use of illegal substances

Inappropriate possession, consumption, sale, or use of controlled substances

Willful mishandling of a controlled substance

Inappropriate use of E-mail or Internet

If a contractor observes inappropriate behavior, the matter should be reported to their immediate supervisor. The immediate supervisor for the contractor will then report the matter to the Lincoln Contractor Administration Management. If the behavior is an immediate threat to the health and well being of colleagues or contractors, the matter should be reported to Pfizer Security immediately. If Pfizer Security can corroborate the behavior and determines the behavior necessitates removal of the individual, the contracting firm responsible for the individual, the management of the contractor work area, and/or Lincoln Contractor Administration Management for the area will be notified to facilitate the removal of the individual.

If the behavior cannot be corroborated, the contractor may proceed to work. If the contractor refuses to be detained by a security guard, they are subject to immediate removal from the site.

g Use of Cafeteria

The cafeteria is open to Contract Workers only during regular service hours. A proper amount of cleanliness is expected while in the cafeteria. The Pfizer Representative is responsible for these determinations.

Strict restrictions exist for food (includes gum) at the site. Food and gum are allowed only in designated locations. The contract administrator will designate a location for break and lunch activities if required or the contractor will be directed to eat in their vehicle.

h Internal Documents and Confidentiality

All internal documents that a Pfizer contractor may come in contact with are the intellectual property of Pfizer. They may not be removed form the site without the written permission of the Lincoln Site Lead.

Security

a General:

Access/egress rules apply to all personnel on site. All Contractors shall attend applicable “Good Manufacturing Practices or GMP training (i.e. Personnel & Equipment Trafficking, GMP Documentation, etc)” prior to accessing “Controlled” areas. The Pfizer Contract Administrator (PCA) shall identify those areas of the facility which require “controlled” access/egress to maintain Good Manufacturing Practices (GMP) and communicate same to all contractors.

a. No contractor is to enter Pfizer construction site, or attempt entry into the existing buildings without proper identification. i.e. Proper display of their Contractor Badge at all times, unless they are working in a GMP area.

b. Only designated site roads and gates are to be used for entry or exit.

c. Unauthorized vehicles parked on site or vehicles parked in areas other than assigned will be towed. Vehicle damage, towing and storage charges will be the vehicle owner’s responsibility.

d. Vehicles parked or operated on site are subject to search without prior notice. Failure to permit a search shall result in the vehicle and contract employee being barred from the site.

e. Reckless and/or irresponsible vehicle or machinery operation shall result in punitive measures deemed appropriate by the owner.

f. Visitors shall not be permitted in the construction areas unescorted.

g. Overtime and weekend work will be scheduled with Pfizer Security in advance. It shall be the contractor’s responsibility to notify Pfizer Security, Engineering, and the Construction Manager.

h. No cameras or recording devices will be allowed on Pfizer property without approval.

j. Contractors shall enter/leave manufacturing facilities through approved/designated points of entry only.

k. Contractors are not to block open any external doors unless previous arrangements have been made with their Pfizer Contract Administrator (PCA) to implement appropriate isolation precautions.

l. Obey all posted speed limit and stop signs on site.

b Pfizer Engineering or Security:

a. Designate on site parking areas for Contractor personnel.

b. Designate access and egress routes for contractor and associated vehicles.

c Contractors:

All construction / maintenance / services material should be properly contained and protected in approved containers in such a way that none of its contents will spill, disperse, escape, flow or adhere to personnel, clothing, machines, walls, floors, ventilation systems, etc. The Contractor shall have copies on-site of all Material Safety Data Sheets (MSDS’s) or other required information for all chemicals the contractor will bring onto the site.

a. Each contractor shall be responsible for his/her own security and that of his/her subcontractors in accordance with the coordinated safety program.

b. Providing additional field office security beyond that provided by Owner’s Security Department. Where additional security measures are instituted, advise the Project Safety Manager, Project Engineering and Pfizer Security Management.

c. Providing a list of supervisory personnel (name, address, and telephone number) to their Pfizer contact, who will be available during non-work periods to assist, in the event of a security breach and/or emergency situations.

d. Advising employees, contractors, and suppliers of site speed limits and security measures.

e. Providing identification of all equipment and machinery by paint scheme, I.D. tag or contractor’s name painted in a prominent location.

f. Disabling all motorized machinery, i.e. front-end loaders, backhoes, bulldozers, etc., during non-work hours to prevent unauthorized operation.

g. All deliveries shall sign in at the guard check point and report to the appropriate contact prior to proceeding on site. After hour deliveries must be coordinated with the Pfizer Engineering and Plant Security.

d Independent Consultants

Independent Consultants must have a signed agreement with Pfizer before work can commence. The type of agreement must mirror the type, scope, and complexity of the work to be performed. All information necessary to select and complete the different types of agreements are defined in the NOTES TO USERS – STANDARD SERVICE, CONSTRUCTION AND EQUIPMENT AGREEMENTS documents available from Pfizer Procurement or on the internal Pfizer webpage as follows: and from the center menu select Global Engineering. At the Global Engineering menu select “Global Engineering Team”, then select “Partners” and then select “Bidding and Contract Documents”. From the document listing that appears select the”Notes to Users” v. 1.0.doc document. Please note that these documents are read only.

Addendums to these agreements are allowed to move the negotiations process along, however the addendums/ changes must be approved by the appropriate Pfizer legal representative.

e Construction Site Security:

The Owner will provide security services, as the need dictates. This security in no way limits any contractors of their contractual duties, obligations and responsibilities to insure its trailers, vans, vehicles, equipment, tools, gang boxes, storage areas, etc., are properly secured at the end of each working day.

NOTE: The Pfizer Project Manager and Construction Manager reserve the right to enforce all requirements of both the security and safety regulations as set forth in this program. Removal of employees and termination of contracts are final means of enforcement. Legal action and prosecution shall be taken when appropriate. The intent of these guidelines is to make all employees aware of the minimum requirements of the project; to provide a safe, secure work place.

Safety

a Emergency Numbers

Fire Dial 2456

Injury /Medical Dial 2456

Explosion Dial 2456

Haz-mat Dial 2456

Bomb threat Dial 2456

Mail threat Dial 2456

Emergency from a cell phone 441-2456

Non-Emergency Spills/Releases

(solid, liquid or gas) Dial 441-2456

Contact Phone Numbers

Security Dial 2267

Health and Wellness Dial 2974

b General Guidelines

How to make an emergency call

Each of us is responsible for reporting an emergency. Following this simple guide of instructions will ensure that emergencies are reported accurately and that effective action can be taken.

• Please remain calm and speak clearly so that the dispatcher can understand you.

• Let the dispatcher guide the conversation. He or she will need specific information so be prepared to provide the following details:

o Your name and the number you are calling from

o Your building number and exact room location

o Type of emergency you are reporting (fire, injury, security emergency)

• The dispatcher will let you know when all of the information is recorded and will give you instructions about the next steps.

c Fire Response Procedures

Preparation

• Know the location of your building egress routes and exits. Refer to posted emergency maps located throughout the building.

• Know the location of your Evacuation Assembly Area.

Response

• If you discover smoke or a fire in your work area:

o Dial 2456 and report the fire immediately

o Activate the nearest fire alarm

o Secure ongoing process (if safe to do so)

o Ensure all people are proceeding to their Evacuation Assembly Area

• Evacuation Assembly Areas

o B1 – Report to outdoor assembly areas

o B2 – Report to outdoor assembly areas

• Pfizer Unit Leads to verify that their work areas have been swept and no known personnel are still in the affected area.

• If you know a person is down or still in the building, report directly to the Incident Commander at the scene.

• If you have critical information related to the fire or the facility, report directly to the Incident Commander at the scene.

• Once at the Evacuation Assembly Area:

o Unit leads should account for everyone in their unit

o Await further instructions from the Pfizer Incident Command

o Do no re-enter the work area until all-clear is given

Other Tips

• Know where to find the nearest fire alarms

• Firefighting should be left to trained staff

• Only authorized personnel should use fire hoses and breathing apparatus

• If you are caught in a fire, always crawl along the floor to minimize the effects of inhaling smoke or other fumes

• If your clothes catch on fire, do not run. Stop where you are, drop to the ground and roll over and over until the flames are smothered

• If you are disabled, ensure that plans have been made for your safe evacuation and the Fire Station knows your work location. Some buildings have designated areas (area of refuge) where people who are unable to use the stairs can wait for assistance.

d Four Categories of Fire

All fire extinguishers are labeled using standard symbols. A red slash through the symbol means that the extinguisher is not suitable for that particular category of fire. If the symbol is missing, this means that the extinguisher has not been tested for a given category of fire, but it may be used if no other extinguisher is available.

Ordinary Combustible

e.g. Paper wood, cardboard, cloth and upholstery

Flammable Liquids

e.g. alcohol, solvents, paint, oil and greases

Energized Electrical Equipment

e.g. wiring, fuse boxes, machinery and appliances

Combustible Metals

e.g. magnesium, titanium and sodium

Warning: It is very dangerous to use water or a Type A extinguisher on

any oil, grease or electrical fire.

e How to Use a Fire Extinguisher

Remember the PASS method

Pull the pin from the extinguisher handle.

This unlocks the lever, allowing you to use

the extinguisher.

Aim the hose or nozzle horn at the base

of the fire.

Squeeze the lever to activate the extinguisher.

release the lever to stop

Sweep the extinguisher agent across the

base of the fire.

Warning: Portable Fire Extinguishers discharge their contents

within 15-30 seconds.

- Do not attempt to fight a fire that is large or spreading.

- Look out for any dangerous or flammable materials

near the fire

- Know what is burning and be sure you are using

suitable fire extinguisher

- Look for unobstructed escape route in case you are

unable to extinguish the fire

f Tornado Sheltering Procedures

Preparation

• Know the location of your Tornado Shelter ahead of time. Shelters are assigned for each site building – refer to the posted building emergency maps. When visiting another building, refer to that building’s emergency maps for the assigned tornado shelter.

Response

• Tornado Watch ( Issued by the National Weather Service (NWS) for Lancaster County)

o Notification – PA announcement

o Be sure everyone in your area is aware of the announcement and establish direct radio communications with essential plant operators

o Do not start any new processes

o Be prepared to secure on-going processes

o Management should identify essential plant operations (See Tornado Warning below)

o Stand by for further instructions

• Tornado Warning ( Issued by the National Weather Service (NWS) for Lancaster County)

o Notification – PA announcement, Pfizer outdoor emergency warning siren*, strobe lights and auto-call bells where available.

o Secure any on-going processes

o Proceed immediately to your primary tornado shelter

o Unit leads to verify that their work areas have been swept and no known personnel are still in the building. Exception: Essential Plant Operations

o Essential Plant Operators should stay at their work stations and stand by for further PA or company radio announcements.

o Do not go your locker room or change clothes

o If you are disabled, ensure that plans have been made for your safe evacuation to your tornado shelter

• Take Cover (Site Specific threat)

o Notification – one or more of the following:

o PA announcement, outdoor emergency warning siren*, company radio or other means

o All personnel (including essential plant operators) should go immediately to the nearest tornado shelter

o See shelter maps in Emergency Procedures Handbook Lincoln

o Exception: If you do not have time to reach a primary or secondary shelter, go directly to an enclosed windowless area at the lowest level of your building, such as a stairwell or internal room/restroom. Crouch down and cover your head.

• Once at the Tornado Shelter

o If you know a person is down or still in your building, call Central dispatch (2456)

o Await further instructions from Pfizer Incident Command

o Do not leave the shelter until the all-clear is given

Other Tips

• Do walk to your shelter

• Do take your security badge and personal belongings if readily available

• Do escort your guest with you to the shelter

• Do use the stairways

• Do not use the elevators

g Injury/Medical Response Procedures

Injury or Illness Requiring Immediate Attention

(to any person on-site, including colleagues, contractors or visitors)

• Dial 2456 and report the injury or illness immediately

• Stay on the phone with the dispatcher and be ready to provide the following:

▪ Nature of the problem

▪ Exact location of the victim

▪ Access point to the area

• Stay with the victim until help arrives

• Provide first aid if you are trained to do so

Contractor incidents must be reported to LCA personnel immediately. The Contractor Incident Report Form can be found on the Lincoln Contractor Administration webpage:



Problems Not Requiring Immediate Attention

• Less urgent problems may be seen in the on-site Health and Wellness Clinic. To confirm that they are open, contact the clinic at the number listed below:

h Security

In an emergency, Security Officers have the latest information available from the Site Dispatch Center and are regular radio contact with emergency responders. They are in the best position to direct you to safety and protect our resources. When an emergency is declared, following the directions of Security Officers becomes critical to your safety and the safety of others.

When a building evacuation is announced, please take your badge and any personal effects which are in your immediate control with you when you evacuate. Don’t return to your office or area to retrieve items. Don’t return to your work areas until an all clear has been announced.

Emergencies can happen at any time. Please be sure to obey parking signs and directions, being especially careful no to block fire lanes or other marked emergency access points.

i Building Emergency Maps

Building Emergency Maps are located in occupied buildings throughout the Pfizer Lincoln Site

j Evacuation Procedures

Evacuation of personnel may be necessary for emergencies involving hazardous materials, workplace violence, bomb or mail threats, etc.

Preparation

• Know the location of your building egress routes and exits. Refer to posted emergency maps located throughout the building.

• Know the location of your evacuation Assembly Area

• Unit Leads should pre-establish unit meeting points/locations within your Evacuation Assembly Area to help account for everyone in your unit.

Response

• Individual Noting the Condition

o Take immediate measures for protection from the hazard

o Warn others in the affected area

o Dial 2456 to report emergency to Central Dispatch

o Follow PA instructions

o Move to your Evacuation Assembly Area if conditions require immediate evacuation

• Personnel in Affected Area

o Take immediate measures for protection from the hazard

o Secure on-going processes (if safe to do so)

o Follow PA instructions

o Move to your Evacuation Assembly Area if conditions require immediate evacuation

• Building Evacuation

o If a building evacuation order is given, proceed in an upwind direction to your Evacuation Assembly Area or other location as directed by Central Dispatch or the Incident Commander. Perform a sweep of your work area as you leave to ensure all personnel are evacuating

• Evacuation Assembly Areas

o B1- Report to Outdoor Assembly Areas

o B2-Report to Outdoor Assembly Areas

• Pfizer Unit Leads to verify that their work areas have been swept and no known personnel are still in the affected area.

• If you know a person is down or still in the building, report directly to the Incident Commander at the scene.

• If you have critical information related to the incident, or the facility, report directly to the Incident Commander at the scene.

• Once at the Evacuation Assembly Area:

o Unit leads should account for everyone in their unit

o Await further instructions from the Pfizer Incident Command

o Do no re-enter the work area until all-clear is given

Other Tips

• If you are disabled, ensure that plans have been made for your safe evacuation and the Central Dispatch knows your work location. Some buildings have designated areas (area of refuge) where people who are unable to use the stairs can wait for assistance.

k Emergency Alarms

Emergencies will be announced via a public address system.

The emergency alarms are:

FIRE – Buzzer/strobes activate with no accompanying voice announcement.

TORNADO – Repeating tone followed by voice indicating a tornado warning.

AREA-WIDE EVACUATION – Fire tones followed by voice indicating the need to evacuate.

l Emergency Response Guide

Refer to posted Emergency Response Guides at laboratory entrance and other select locations for guidance in responding to chemical and biological spills

m Safety Equipment

All Pfizer units have specific guidelines governing the use of Safety showers, Eye wash stations, fire alarm boxes and fire extinguishers. Contractors should familiarize themselves with the location and use of these types of safety equipment.

Criminal Background Check Policy

Policy Scope

All contracting agencies and other organizations (“Agency”) providing services to Pfizer are required to ensure that their employees, independent contractors, consultants, (and all other individuals they assign to work on Pfizer premises and/or projects) successfully pass a criminal background check according to the criteria listed. It is the organization or Agency’s responsibility to have these checks performed, and have documentation of clean record in place, prior to any work starting at the site, at their expense. The contracting firm must also insure their compliance with this policy is current if work at Pfizer is not continuous.

Disqualifying Offenses

Felonies

- All felony convictions within the last seven (7) years except as restricted by applicable federal, state and local laws.

- All felony drug convictions (no time limit) where the individuals former position, or the Pfizer project to which the individual is being considered for placement, involve handling of pharmaceutical in any capacity.

Misdemeanors

The following misdemeanor convictions within a period of five (5) years except as restricted by applicable federal, state and local law:

Arson

Assault

Battery

Child abuse and neglect

Criminal contempt

Criminal conversion (Theft)

Criminal mischief

Escape

Evading arrest

Failure to stop

Harassment (includes telephone)

Hit and run collision

Indecent exposure

Injury to personal property

Larceny

Petty theft\Possession of controlled drugs

Possession of drug paraphernalia

Possession of marijuana

Possession of stolen goods

Prostitution

Purchasing alcoholic beverages for a child

Resisting arrest

Sexual offenses

Theft by check

Trespassing

Unlawful sales to minors (alcohol and tobacco)

Vandalism

Violation of probation

Violation of protection order

Welfare violation code

Time restrictions calculation

All hiring time restrictions for felony or misdemeanor convictions are calculated from the date of release from prison system following incarceration.

Pending Charges

An individual charged with a disqualifying offense may not be placed with Pfizer while any such charge[s] is pending. The individual may be considered for placement if exonerated of the charge[s].

Outstanding warrants

An individual with an outstanding warrant for a disqualifying offense may not be placed with Pfizer until the warrant has been dismissed.

Failure to disclose

Any individual who fails to disclose any felony and/or misdemeanor conviction[s] prior to the Agency’s submission of the individual’s background information for the criminal record check may not be placed with Pfizer.

Non-Disqualifying Offenses

A conviction of one of the following offenses within a five (5) year period (as long as the offenses did not occur within the previous twelve (12) months), and there are no other convictions of any other disqualifying offense:

Breach of Peace

Disorderly Conduct

Failure to appear

Motor Vehicle Record (MVR)

The following MVR check is required prior to the placement of any individual in a position that requires the operation of a motor vehicle on behalf of Pfizer:

|Disqualifying Criteria |

|Invalid, suspended, or revoked drivers license |

|1 conviction of driving under the influence (DUI) within the preceding year, 2 or more DUI convictions, no time limit |

|3 or more moving violations within the last 3 years |

|Any accumulation of suspensions of over 1 year in length within the last 3 years |

|More than 2 accidents with indication of fault within the last 3 years |

|More than 3 accidents, no time limit |

Debarment Lists

All individuals will be checked against the following debarment / exclusion lists maintained by the following agencies:

1) Federal Department of Health and Human Services



2) General Services Administration

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3) Federal Drug Administration



No individual whose name appears on any of these lists may be placed in any assignment with Pfizer.

Retention of Records and Audit

The agency must retain records demonstrating its compliance with these background check requirements for each individual placed with Pfizer. Pfizer reserves the right to audit the Agency’s compliance, and the Agency will provide these records to Pfizer upon request.

Compliance with Applicable laws and Indemnification

The Agency will implement these background check requirements in a manner that complies with all relevant federal, state and local laws. The Agency agrees to indemnify and hold Pfizer harmless for all claims damages, losses and liabilities (including claims or demands made by its employees, agents consultants, independent contractors, and applicants) as a result of the Agency’s compliance or noncompliance with the forgoing requirements.

Contract Firm Non-Compliance Process

a Scope

The scope of this guideline includes all service providers to the Lincoln Site. The guideline addresses actions to be taken with companies not adhering to Pfizer policies and procedures and does not address individuals working for service providers.

For the purposes of this guideline, any company under contract to Pfizer will be defined as service provider. Individuals working for service providers will be referred to as contractors. Any requirement for operating on the Lincoln Site, whether termed policy, procedure, requirement or governmental regulation, will be considered a “policy” for the purposes of this document.

b Purpose

The purpose of this guideline is to ensure that service providers comply with Lincoln Site requirements, procedures and policies as well as applicable federal, state and local regulations. Additionally this guideline will ensure that there is a consistent approach to handling non-compliance to site policies by any service provider performing work on the Lincoln Site.

c Responsibilities

PGM Procurement – Midwest Regional PGM Procurement will be responsible for the official notification to any service provider and executing the notification requirements of this guideline. Procurement will attend any and all meetings with service providers to discuss actions taken in regard to this guideline.

Lincoln Contractor Administration (LCA) – LCA will be responsible to document all incidents resulting in violations of policies and provide necessary data to procurement to properly document the incident.

Pfizer Sponsor – The Pfizer sponsor is the Pfizer colleague responsible for having the service provider on site and or the business representative who initially helped procurement establish the contract. Once informed, the Pfizer sponsor will be part of all discussions held with the service provider regarding non-compliance with site policies and subsequent actions taken with regard to the non-compliance incident(s) by the service provider.

d Procedure/Process

Violations of site policies may be brought to the attention of the involved service provider by any Pfizer colleague. If the violation is believed to be of a nature to cause serious harm or injury to personnel, the environment, or Pfizer property, work shall be stopped immediately. Violations of lesser magnitude should be brought to the attention of the service provider, Lincoln Contractor Administration (LCA) and the Pfizer sponsor. LCA will document the incident in accordance with this guideline as well as notify the sponsor of the service provider involved. Identified violations must be promptly addressed and corrected.

Violations may result in work stoppage (at the Contract firm’s cost) and result in loss of current and future work for the contract firm. Also note that the individuals involved in any incident/violation may face temporary to permanent removal from the Pfizer site. Pfizer encourages the contract company to take appropriate actions with their employees to ensure that no future violations/non-compliance situations arise. On-going non-compliance with site policies will be handled as outlined below. However, note that Lincoln Contractor Administration (LCA) and Procurement can re-assess and increase the severity of the action if deemed necessary. Written notifications will be issued during a meeting with LCA, Procurement, the contract firm and other Pfizer representatives as necessary. The contract firm may be required to complete a corrective action plan to ensure that the violation has been adequately addressed.

e Non-compliance Notification Process

Observation – Service Provider Immediate Action

If a violation of policy is discovered and brought to the attention of the service provider (management) and immediate (and appropriate) actions are taken with the affected employees, the issue will be documented but the violation will not result in initiation of the process outlined below. Violation of policies resulting in potential for danger to life, the environment of Pfizer property may not be listed as observations. Any violation involving safety permits (LOTO, Confined Space, Hot Work, Line Entry, etc.); fall protection, personal protective equipment and electrical safety will automatically be treated as a first violation.

Non-Compliance Notification Process

1st Violation – A discussion of the violation will be held between Midwest Regional PGM Procurement, LCA, Pfizer Sponsor and the management of the service provider. The discussion will be documented with a copy provided to the service provider. The documentation will stay on file for 90 days or until an additional violation is noted.

2nd Violation - A discussion of the violation will be held between Midwest Regional PGM Procurement, LCA, Pfizer Sponsor and the management of the service provider. The service provider will be notified that for a period of 6 months any additional violations of policies or non-compliance situations may result in termination of their contract. The service provider will receive written notification from Midwest Regional PGM Procurement. Notification of a second violation may result in lost bidding opportunities as well as lost opportunities for on-going work.

3rd Violation - A discussion of the violation will be held between Midwest Regional PGM Procurement, LCA, Pfizer Sponsor and the management of the service provider. The contract between Lincoln PGM and the service provider will be terminated according to the provisions in the contract for a period of not less than 1 year. Reinstatement of the contract will be dependent on the needs of Pfizer.

Contractor Responsibilities Regarding Subcontractors

A Subcontractor is defined as any agent, representative, consultant, advisor or other third party employed or used by the Contractor in the performance of the Work.

Subcontractors are to be pre-qualified according to Pfizer Standards, by the Lincoln Contractor Administration group, prior to site access being granted. The subcontractor firm representative must complete the Subcontractor Prequalification Form (available on the LCA website below). The information contained in the form must be reviewed and approved by the prime contract firm, approved, and submitted to LCA for final approval.

Prime contractors that use subcontractors shall be responsible for the subcontract firm’s adherence to all the Pfizer requirements, which are contained in the Qualification Form.

The Lincoln Subcontractor Qualification Form is available on the Pfizer Intranet Lincoln Contractor Administration webpage at the following web address:



End of Policy

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