PWS-Surgical.pdf

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PERFORMANCE WORK STATEMENT

FOR

SURGICAL INSTRUMENT PREVENTIVE MAINTENANCE,

REPAIRS, TESTING, INSPECTION, AND TRAINING

AT

JOINT BASE ELMENDORF-RICHARDSON, ALASKA

30 Sep 2019

FA5000-20-R-0004

Attachment 2: PWS

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Surgical Instruments Services

Table of Contents

SECTION I DESCRIPTION OF SERVICES

1.0 General Scope Page 3

1.1 Overview Description of Services/Introduction Page 3

1.2 Background Page 3

1.3 Objectives Page 3

1.4 Scope Page 4

1.5 Inherently Government Functions Page 4

1.6 Period of Performance Page 4

1.7 Specific Tasks Page 4

1.8 Historical Data Page 6

1.9 Minimum Qualifications Page 6

SECTION II SERVICE SUMMARY

2.0 Service Summary Page 7

SECTION III GOVERNMENT FURNISHED PROPERTY and SERVICES

3.0 Government Furnished Services Page 8

3.1 Emergency Services Page 8

3.2 Refuse Collection Page 8

3.3 Security Police and Fire Protection Page 8

3.4 Telephone Service Page 8

3.5 Utilities Page 8

3.6 Government Furnished Property

SECTION IV GENERAL INFORMATION

4.0 Contractor Personnel Page 9

4.1 Quality Assurance Page 10

4.2 Physical Security Requirement Page 11

4.3 Hours of Operation Page 11

4.4 Contractor Access To Air Force Installations Page 11

4.5 Use of Government Employees Page 12

4.6 Emergency Operations Page 12

4.7 Contractor Representative Page 13

4.8 Miscellaneous Paragraphs Page 13

SECTION V APPENDIX 1

5.0 Definitions Page 16

5.1 Acronyms Page 17

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SECTION I

DESCRIPTION OF SERVICES

1.0 GENERAL SCOPE: This is a non-personnel services contract to provide Surgical instrument preventive maintenance, repairs, testing, inspection and training. The Government shall not exercise any supervision or control over the contract service providers performing the services herein. Such contract service providers shall be accountable solely to the Contractor who, in turn is responsible to the Government.

1.1 Overview Description of Services/Introduction: The Contractor shall provide all management, personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to perform surgical instrument preventive maintenance, repairs, testing, inspection and training as defined in this Performance Work Statement except for those items specified as Government Furnished Property and Services. The Contractor shall perform to the standards in this contract. This includes the planning, coordination, and surveillance of the activities necessary to ensure disciplined work performance and timely resources application to accomplish all tasking under the contract.

The Contractor shall be responsible for maintaining communication with the Contracting Officer (CO) and the Contracting Officer’s Representative (COR), and to immediately notify both the CO and the COR of any problems that would prevent timely performance of this contract. The Contractor is responsible for and required to implement, and maintain management control systems necessary to plan, organize, direct, and control all activities under this contract.

1.2 Background: The 673d Medical Group (673 MDG) is a Department of Defense (DoD), Tertiary Care Medical Center and Lead Agency for 166,000 beneficiaries. It provides or arranges comprehensive community and referral health care, readiness, education, and DoD/VA Joint Venture. It annually produces over 239,791 outpatient visits, 2,872 admissions, 3,147 surgical procedures, 26,190 dental visits and 972 newborn deliveries.

The 673 MDG is currently seeking a company that can provide the following services to repair, refurbish, and assess for replacement surgical instruments for use in operating room procedures. This will include the service and repair of surgical instruments that are used in (but not limited to) the following clinics and surgical services at the 673 MDG and Alaska VA HCS; Ophthalmology, General, Otolaryngology, Orthopedics, Podiatry, Urology, OB/GYN, Plastic Surgery, Oral Maxillofacial, Dental. An average of 100-120 sets and individual instruments totaling 3000-4000 require servicing each visit.

1.3 Objectives: Preventive Maintenance (PM) / Schedule repairs, refurbishment and assessment for replacement will include but is not limited to specialty trays by Service (Ortho, ENT etc.) scissors, needle holders, curettes, hemostats, graspers, laparoscopic instruments, surgical knifes, etc.

These services are periodic in nature and are required to maintain the equipment in such a condition that it may be operated in accordance with its intended manufacturer’s design and functional capacity with minimal incidence of malfunction or inoperative conditions.

The contractor shall ensure that the repairs and service functions are performed in conformance with ANSI- AAMI ST-79:2017 and specifications stated by the instrument manufacturer in their Instructions for Use (IFU). The contractor shall provide support consistent with the policies and standards of the customer and it’s governing authority (e.g., DoD, Department of the Air Force, Pacific Air Force (PACAF), Joint Base Elmendorf-Richardson (JBER), 673 Medical Group, Joint Commission (JC), American Association of Medical Instrumentation (AAMI), and the International Association of Health Care Central Service Material Management (IAHCSMM). The contractor must be prepared to service a large assortment of instruments that are not limited to Minimally Invasive Surgery (MIS) instruments and micro instruments. These instruments require special expertise and a specific quality of replacement parts.

Upon completion of repair, refurbishment, and testing of the submitted trays and instruments, the contractor must return the equipment to the Sterile Processing Department (SPD). Additionally, the contractor must also

Page - 4 - of 17 provide a summary document upon delivery of processed instruments containing the following information: date of repair, instrument type, type of repair, and cost (if indicated include optional digital pictures of at least 250X magnification), detailing their findings of the damage, wear, tear and overall condition of the instrument.

Frequent updates should be provided to SPD staff providing feedback on what was found and what SPD staff could do to improve results. An informal out brief with the OR Flight Commander or their designee shall be provided at the end of each visit.

1.4 Scope: The contractor shall provide these services to include but not limited to sharpening, adjusting, aligning, straightening, refurbishing, calibrating, cleaning, stain removal, polishing, lubricating, adjusting, replacing parts, of various individual surgical instruments sets and operating room (OR) procedural instrument trays. Instruments will be provided individually or as components of a specialty tray. All instruments shall be maintained in proper operating conditions as specified by the original manufacturer and in compliance with ANSI-AAMI ST- 79:2017. Instruments are to be retrieved from and delivered to the SPD.

1.5 Inherently Governmental Function: The Contractor shall not perform Inherently Governmental functions as defined in FAR Subpart 7.5 in relationship to this PWS.

1.6 Period of Performance: The period of performance shall be for one (1) Base Year of 12 months and two (2)

12-month option years. The Period of Performance reads as follows:

Base Year Option Year 1 Option Year 2

1.7 Specific Tasks:

1.7.1 Basic Services: The Contractor shall provide services for repairs, maintenance, and testing of surgical instruments, pneumatic instruments, and surgical instrument containers.

1.7.1.1 The Contractor's employee(s) shall report to the SPD upon arrival at the 673 MDG for the pickup and return of instruments. Repairs will be completed in onsite work area designated by the 673 MDG

SPD.

1.7.1.2 Individual instrument repairs will be performed Monday through Friday between the hours of 0730 –

1630 excluding weekends and national holidays. The contractor shall schedule all on-site services through SPD at 907-580-1004 or 907-580-1006. Deviations must be approved by the SPD Element Leader.

1.7.1.3 In the rare occasions an instrument cannot be repaired onsite, during the scheduled service visit, the contractor will receive written approval with a hand receipt from Government's Contracting Officer Representative (COR) to remove the item from 673 MDG. Instruments will be repaired and returned within 7 calendar days. Instruments should be returned by the vendor via Hand Delivery or Courier Services

1.7.1.4 Single instrument repairs will be picked up and are to be returned within seven (7) days on the next scheduled pick up date.

1.7.1.5 The finish of the surgical instruments will be maintained to manufacturer’s specifications.

1.7.1.6 The manufacturer’s part numbers and catalog numbers shall be preserved on all repaired or refurbished instruments.

1.7.1.7 The repair vendor will not repair surgical instruments marked ‘Pakistan’ as the only such instruments we have are expressly intended for one-time use and are typically discarded afterward.

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1.7.1.8 Instruments that cannot be repaired or refurbished due to cracking, pitting, corrosion, or exceeding life expectancy will be tagged or marked for removal and/or replacement recommendation and returned to

SPD.

1.7.1.9 The repair contractor will provide multiple levels of repair service including, but not limited to same-day turn-around when on site, mail-in repair service, and onsite repair service.

1.7.1.10 The repair contractor will provide multiple technicians for onsite repair.

1.7.1.11 Magnification technology of at least 250X must be utilized during the repair process to diagnose, document, and educate regarding repairs.

1.7.1.12 Surgical instrument maintenance and repair will be handled with care. The contractor will be required to test instruments for accurate alignment, sharpness, insulation and calibration. The contractor will return instruments in as good as new condition. All instruments shall be repaired and maintained in proper operating conditions as specified by the original manufacturer (IFU).

1.7.1.13 The repair vendor will provide SPD staff with education regarding instrument repairs, instrument care and handling, instrument processing, power equipment repairs, laparoscopic continuity testing, and endoscopy instrument repairs which is consistent with and eligible for IAHCSMM certified CEUs.

1.7.1.14 The repair contractor, with the input of the clinical and SPD staff, will implement a Surgical

Instrument Quality Assurance Program (SIQAP) whereas instrument sets will be repaired, documented, and monitored by surgical service and specialty.

1.7.1.15 The contractor must provide a summary document upon delivery of processed instruments containing the following information: date of repair, instrument type, type of repair, cost and (optional digital pictures of at least 250X magnification as indicated), detailing their findings of the damage, wear, tear and overall condition of the instrument.

1.7.1.16 All single instrument and surgical trays picked up/delivered by contractor will be properly listed for accountability verification.

1.7.1.17 Repaired instruments returned to SPD will be on a detailed list document provided by the contractor containing the following information: date of repair, instrument type, type of repair, cost and (optional digital pictures of at least 250X magnification as indicated), detailing their findings of the damage, wear, tear and overall condition of the instrument.

1.7.1.18 A repair report, business review, and Surgical Instrument Quality Assurance Program (SIQAP) update shall be provided to the COTR, and Chief of SPD following each scheduled visit.

1.7.1.19 The 673 MDG Sterile Processing Department (SPD) will inspect all repaired instruments. The Surgical

Service Operating Room will perform a serviceable quality check of instruments and any instruments that fail will be returned to SPD for re-processing to the contractor.

1.7.2 Maintenance by Specialty:

1.7.2.1 Surgical instrument tray maintenance, repairs, and inspections will be performed based on the frequency determined by the Surgical Instrument Quality Assurance Program (SIQAP).

1.7.2.2 All instruments that can be disassembled will be disassembled and undergo a detailed contractor inspection.

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1.7.2.3 Instruments will not be altered, changed or tampered with and will be repaired following manufacturers’ original design specifications (per IFU) and in compliance with ANSI-AAMI ST-79.

1.7.2.4 Instruments such as Kerrison Rongeurs, Biopsy Punches, Graspers, Scissors, and Endoscopic –

Arthroscopic devices will be disassembled for maintenance and repaired. They will also be sharpened and aligned in accordance with the manufacturer’s original specifications and in compliance with ANSI-

AAMI ST-79.

1.7.2.5 Surgical Picks, Nerve Hooks, Needle Holders, etc., will be straightened or aligned as to maintain their original manufacturer’s configuration.

1.7.2.6 Specific custom made instruments will be repaired in coordination with operating room surgeons (end user) specifications.

1.7.2.7 Suction tubes (Poole, Adson, Frazier Baron, and Yankauer) will be inspected, and interior lumen flushed and inspected.

1.7.2.8 All instruments will be stain free with a finish that complies with the manufacturer’s specifications.

1.7.2.9 Delicate sharp, pointed eye instruments will be returned covered with appropriate tip protectors.

1.8 Historical Data: The tasks described above have been performed in the past by a contracted surgical instrument repair vendor.

1.9 Minimum Qualifications:

1.9.1 Employees must have current ISO9001 and ISO13485 (medical device) certifications; ASQ (American

Society for Quality) certification and receive CQI (Certified Quality Inspector) training.

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SECTION II

SERVICE SUMMARY

2.0 The Contractor service requirements are summarized into performance objectives that relate directly to mission essential items. The performance threshold briefly describes the minimum acceptable levels of service required for each requirement. These thresholds are critical to mission success.

Performance Objective (The Service required—usually a shall statement)

PWS

Paragraph

Performance Threshold (This is the maximum error rate. It could possibly be “Zero deviation from standard”)

Method of Surveillance

The Contractor shall provide detailed document list of repaired instruments.

1.7.1.17

Zero

100% Inspection

SPD will inspect all repaired instruments

1.7.1.19

One

100% Inspection

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SECTION III

GOVERNMENT FURNISHED PROPERTY, EQUIPMENT, AND SERVICES

3.0 GOVERNMENT FURNISHED SERVICES:

3.1 Emergency Medical Services: The 673d Medical Group will provide emergency medical services for Contractor personnel in performance of services under this contract on Joint Base Elmendorf- Richardson (JBER), AK IAW Air Force Instruction (AFI) 41-115 Chapter 1. The Contractor shall reimburse the Government for treatment provided at the current reimbursement rate for non-authorized user IAW AFH 41-114, paragraph 42. The Contractor shall provide to the 673d Medical Group, the name of a physician and/or hospital to which injured personnel can be transferred for further treatment and care after receiving initial emergency treatment at JBER, AK. All mishaps will be promptly reported to the base safety office through the COR.

3.2 Refuse Collection: The Government will provide refuse collection services. The Contractor shall take refuse to the nearest dumpster on a regular basis. The Contractor shall comply with all installation recycling programs, refuse volume reduction programs, and hazardous waste collection policies IAW base policies.

3.3 Security Police and Fire Protection: Phone number for 673d Security Forces Squadron, 552- 4444; Fire

Protection, 911.

3.4 Telephone Service: The Government will provide local and DSN telephone services FOR OFFICIAL

USE ONLY use at no cost to the Contractor. Commercial long distance calls shall be at the Contractor’s expense.

3.5 Utilities: The Government will provide all electricity, water and sewage at no additional cost to the

Contractor. The Contractor shall instruct employees in utilities conservation practices. The Contractor shall be responsible for operating under conditions that preclude the waste of utilities, which include turning off the water faucets or valves after using the required amount to accomplish requirements under this PWS.

3.6 Government Furnished Facilities: The Government will provide the necessary workspace for the

Contractor staff to provide the support outlined in the PWS necessary to perform maintenance, repair, and training.

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SECTION IV

GENERAL INFORMATION

4.0 CONTRACTOR PERSONNEL:

4.0.1 Alcohol/Drug Use: The consumption of alcoholic beverages or illegal drugs by Contractor personnel, while on duty, is strictly forbidden. The Contractor shall immediately remove any employee who is under the influence of alcohol or drugs.

4.0.2 Appearance: Due to interaction with Distinguished Visitors, Contractor personnel shall present a neat appearance. Contractor’s uniform must be easily recognized. This shall be accomplished by wearing distinctive clothing bearing the name of the company and by wearing badges that contain the company name and employee name.

4.0.3 Certifications: Contractor employees shall have current and valid professional certifications and licenses required to perform the work in this PWS. All certification and licensing requirements by Federal, State, and local agencies shall be complied with at the Contractor's expense.

4.0.4 Contractor Qualifications: The Contractor shall utilize employees possessing adequate training, skills, and knowledge to perform the requirements of this contract.

4.0.5 Employee Training: The Contractor shall give all training required to meet requirements of the PWS unless otherwise specified within the PWS or as otherwise approved by the CO. The Contractor shall maintain training and experience records for each employee during the period of this contract that reflect sufficient personnel are qualified to accomplish all tasks required by this contract. Provide status of employee training upon Government request.

4.0.6 English Language: Employees who deal directly with customers will be required to effectively communicate with the customers in English. This requirement is strictly for the purpose of efficiently performing the contract tasks. The Contract Manager will be required to read and write English.

4.0.7 Identification of Contractor Employees: All contract personnel attending meetings, answering

Government telephones, and working in other situations where their Contractor status is not obvious to third parties are required to identify themselves as such to avoid creating an impression in the minds of members of the public that they are Government officials. They must also ensure that all documents or reports produced by Contractors are suitably marked as Contractor products or that Contractor participation is appropriately disclosed. Contractor personnel will be required to obtain and wear badges in the performance of this service.

4.0.8 Performance Flexibility: The Contractor shall maintain the flexibility to perform command- related tasks as deemed absolutely necessary for successful mission accomplishment.

4.0.9 Personnel Roster: The Contractor may be required to provide a personnel roster consisting of names and other pertinent personnel data to the requiring activity for the purposes of 100% accountability real-world and exercise situations. The personnel roster shall be updated as individuals are removed and added.

4.0.10 Privately Owned Vehicles: Each Contractor employee driving a privately owned vehicle on the installation must carry minimum liability insurance as required by the State of Alaska. Contractor employees shall adhere to all posted speed limits and shall not use hand-held cellular telephones while driving on the installation for phone calls or texting. Use of seatbelts is mandatory. Any Contractor employee cited for driving under the influence will have their driving privileges immediately revoked for a period to be determined.

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4.0.11 Retainability: Personnel provided under this contract/task order are critical to the mission and shall be considered “key personnel”. The Contractor is expected to minimize employee turnover with respect to personnel performing under the PWS. The Contractor must notify the CO within 24 hours of any change of personnel performing under this contract/task order. Any replacement personnel proposed must meet all minimum qualifications outlined in this PWS and shall be filled within two

(2) weeks. The Government may request to review the candidate’s résumé for replacement personnel prior to the time the personnel change is expected to occur. The Contractor is responsible for providing personnel with the appropriate security clearances and expertise in the related field described in the PWS.

4.0.12 Safety Equipment: The Contractor shall furnish personal safety equipment for its employees in performance of this contract. Safety equipment includes shoes or boots, eyewear, respirators, and gloves.

4.0.13 Safety Threats: The Contractor shall not employ persons for work on this contract if such employees are identified to the Contractor by the CO as a potential threat to the health, safety, security, general well-being or operational mission of the installation and its population.

4.1 Quality Assurance:

4.1.1 Quality Assurance: The Government shall evaluate the Contractor’s performance under this contract in accordance with the Government Performance Plan (provided under separate cover). This plan is primarily focused on what the Government must do to ensure that the Contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s).

4.1.2 Surgical Instrument Quality Assurance Personnel (QAP): The SIQAP will be identified by separate letter. The SIQAP monitors all technical aspects of the contract and assists in contract administration.

The SIQAP is authorized to perform the following functions: Assure that the Contractor performs the technical requirements of the contract; perform inspections necessary in connection with contract performance; maintain written and oral communications with the Contractor concerning technical aspects of the contract; issue written interpretations of technical requirements, including Government specifications; monitor Contractor’s performance and notify both the CO and Contractor of any deficiencies; coordinate availability of GFP, and provide site entry of Contractor personnel. A letter of designation issued to the SIQAP, a copy of which is sent to the Contractor, states the responsibilities and limitations of the SIQAP, especially with regard to changes in cost or price, estimates or changes in delivery dates. The SIQAP is not authorized to change any of the terms and conditions of the contract.

4.1.3 Quality Control Plan (QCP): The Contractor shall develop and maintain an effective quality control program to ensure services are performed IAW this PWS, applicable laws and regulations and IAW best commercial practices. The Contractor shall develop and implement procedures to identify, prevent, and ensure non-recurrence of defective services with special emphasis placed on those services listed in Section 2 of this PWS. The Contractor’s quality control program is the means by which it assures itself that the work complies with the requirement of the contract. The QCP is to be delivered, within 30 days after contract award. After acceptance of the quality control plan the Contractor shall receive the contracting officer’s acceptance, in writing, of any proposed change to his QC system.

4.1.4 Contract Discrepancies: The Government COTR will periodically evaluate the Contractor’s performance using the methods of surveillance listed in Section 2 – Service Summary of the PWS.

Government personnel will record all surveillance observations. When an observation indicates defective performance, the SIQAP will require the Contractor Representative at the site to initial the observation. The initialing of the observation does not necessarily constitute concurrence with the

Page - 11 - of 17 observation, only acknowledgment that he or she has been made aware of the defective performance.

If the Contractor challenges the validity of any observation, and the SIQAP and Contractor Representative cannot come to an agreement, the complaint in question shall be forwarded to the Contracting Officer for resolution. The preferred method of dealing with any valid observation is re-performance, if possible, and at no additional cost to the Government. Repeat observations or an incident that violates safety or environmental regulations shall require the SIQAP to instigate a Corrective Action Report (CAR) through the Contracting Officer. The Contractor shall be given three

(3) business days to respond to the CAR with either an explanation on why it disagrees with the CAR or with its concurrence with the CAR, any disciplinary action taken, and a mitigation plan to avoid repeat occurrences.

4.2 Physical Security: The Contractor shall be responsible for safeguarding all Government equipment, information and property provided for Contractor use. At the close of each work period, Government facilities, equipment, and materials shall be secured.

4.3 Hours of Operation: The Contractor is responsible for conducting business, between the hours of 0730

- 1630 Monday thru Friday except Federal holidays or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings.

For other than firm fixed price contracts, the Contractor will not be reimbursed when the Government facility is closed for the above reasons. The Government will notify the Contractor within 24 hours of such occurrence. The Contractor must at all times maintain an adequate workforce for the uninterrupted performance of all tasks defined within this PWS when the Government facility is not closed for the above reasons. When hiring personnel, the Contractor shall keep in mind that the stability and continuity of the workforce are essential.

4.3.1 Recognized Holidays:

New Year’s Day Labor Day Martin Luther King Jr.’s Birthday Columbus Day President’s Day Veteran’s Day Memorial Day Thanksgiving Day Independence Day Christmas Day

*If the holiday falls on a Saturday, it will be observed on the preceding Friday. If the holiday falls on Sunday, it will be observed on the following Monday.

4.3.2 Place of Performance: The work to be performed under this contract will be performed at the 673d

Medical Treatment Facility, Joint Base Elmendorf Richardson (JBER).

4.4 Contractor Access To Air Force Installations:

(1) The Contractor shall obtain base identification and vehicle passes, if required, for all Contractor personnel who make frequent visits to or perform work on the Air Force installation(s) cited in the contract. Contractor personnel are required to wear or prominently display installation identification badges or Contractor-furnished, Contractor identification badges while visiting or performing work on the installation.

(2) The Contractor shall submit a written request on company letterhead to the Contracting Officer listing the following: contract number, location of work site, start and stop dates, and names of employees and subcontractor employees needing access to the base. The letter will also specify the individual(s) authorized to sign for a request for base identification credentials or vehicle passes.

The Contracting Officer will endorse the request and forward it to the issuing base pass and registration office or security police for processing. When reporting to the registration office, the authorized Contractor individual(s) should provide a valid driver’s license, current vehicle registration, and valid vehicle insurance certificate, to obtain a vehicle pass.

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(3) During performance of the contract, the Contractor shall be responsible for obtaining required identification for newly assigned personnel and for prompt return of credentials and vehicle passes for any employee who no longer requires access to the work site. When work under this contract requires unescorted entry to controlled or restricted areas, the Contractor shall comply with AFI 31- 101, Volume 1, The Air Force Installation Security Program, and AFI 31-501, Personnel Security Program Management. Upon completion or termination of the contract or expiration of the identification passes, the prime Contractor shall ensure that all base identification passes issued to employees and subcontractor employees are returned to the issuing office. Failure to comply with these requirements may result in withholding of final payment.

4.5 Use of Government Employees:

4.5.1 Conflict of Interest: The Contractor shall not employ any person who is an employee of the U.S.

Government if employing that person would create a conflict of interest. In addition, the Contractor shall not employ any person who is an employee of the Department of the Defense if such employment would be contrary to the policies contained in AFI 64-106, Chapter 1, Industrial Labor Relations Activities.

4.5.2 Employment of Spouses/Dependents: The Contractor shall not employ any person who is a spouse or dependent child of a Department of the Air Force or Department of Army employee (either military or civilian) when such employee would be placed in a conflict of interest or appearance of a conflict of interest by virtue of such employment.

4.5.3 Off-duty Military Personnel: The Contractor is cautioned that off-duty active military personnel hired under this contract may be subject to permanent change of station, change in duty hours, or deployment. Military Reservists and National Guard members may be subject to reorder to active duty. The abrupt absence of these personnel could adversely affect the Contractor's ability to perform.

However, their absence at any time shall not constitute an excuse for nonperformance under this contract.

4.6 Emergency Operations:

4.6.1 Military Personnel: The Government retains the option to assign military representatives on a full or part time basis at all contracted sites as deemed necessary for reasons, such as, to receive training, to assist in contingency efforts at site, or to evaluate site performance (not inclusive). The presence of military personnel shall in no way diminish the Contractor’s responsibility to provide the operation services specified in this PWS.

4.6.2 Contingency Plan: The Contractor shall submit a contingency plan to the CO at contract start date, which explains how the Contractor will ensure there are no interruptions of routine contract services due to labor disputes. Such plan shall be approved by the CO prior to Contractor assuming duties under this contract.

4.6.3 Labor Disruptions. The Government reserves the right to take over performance of this contract in the event of a labor strike, bankruptcy, default or period of non-performance by the Contractor’s employees. In such events, the services will be performed exclusively by Government personnel and not a mix of Government and non-striking Contractor employees. At the direction of the CO, the Contractor agrees to remove its non-striking work force from the performance site and not interfere in any way with Government performance. The Contractor further agrees, under such circumstances, to permit the Government to use any essential Contractor-furnished property. The Government will not compensate the Contractor for performance during this period.

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4.7 Contractor Representative:

4.7.1 The Contractor shall provide a contractor representative and alternate(s) who are knowledgeable of Surgical Instrument Repair and Training. The Contractor shall submit the name, address, telephone number and a resume of the Project Manager to the Contracting Officer within two days of contract start date. The list shall be kept current throughout the life of the contract.

4.7.2 The contractor representative or alternate(s) shall have full authority to act for the Contractor on all contract matters relating to daily operation of this contract.

4.7.3 The contractor representative and alternate(s) shall be able to read, write, and speak English.

4.7.4 Qualifications for the Contractor Representative are listed below: The Contractor Representative and alternate(s) must have current ISO9001 and ISO13485 (medical device) certifications; ASQ (American Society for Quality) certification and receive CQI (Certified Quality Inspector) training.

4.8 Miscellaneous Paragraphs:

4.8.1 Conservation of Utilities: The Contractor shall instruct employees in utilities conservation practices.

The Contractor shall be responsible for operating under conditions that preclude the waste of utilities.

4.8.2 Contractor Furnished Property and Services: Except for those items or services specifically stated to be Government-furnished in Section III and any appendixes, the Contractor shall furnish everything required to perform this contract in accordance with all of its terms. The following mentioned requirements are not all inclusive of the Contractor furnished items and services required in the performance of this contract. [Instrument repair list, checklist/delivery receipt, Monthly Invoices]

4.8.3 Data Rights: The Government has unlimited rights to all documents/material produced under this contract. All documents and materials, to include the source codes of any software, produced under this contract shall be Government owned and are the property of the Government with all rights and privileges of ownership/copyright belonging exclusively to the Government. These documents and materials may not be used or sold by the Contractor without written permission from the Contracting Officer. All materials supplied to the Government shall be the sole property of the Government and may not be used for any other purpose. This right does not abrogate any other Government rights.

4.8.4 Right to Inspect: The Government’s rights under this Contract specifically include the right for

Government officials to inspect upon reasonable notice the work site for compliance with environmental, safety and occupational health laws and regulations, whether or not Government is responsible for enforcing them. Such inspections are without prejudice to the right of duly constituted enforcement officials to make such inspections. The Government normally will give the Contractor twenty-four (24) hours prior notice of its intention to inspect, unless it determines the entry is required for safety, environmental, operations or security purposes.

4.8.5 Non-compliance: If the Contractor is found to not be in compliance with any of these regulations, there may be cause for the facility to shut down until Contractor, when within the Contractor’s control or the Government’s, has remedied the problem. Any sanitary deficiencies shall require immediate correction.

4.8.6 Audit: This contract may be subject to audit by any and all cognizant Government agencies. The

Contractor shall make available all records, which it maintains with respect to this contract, to such agencies.

4.8.7 Failure to Insist On Compliance: The failure of Government to insist, in any one or more instances, upon performance of any of the terms, covenants or conditions of this contract shall not be construed as a waiver or relinquishment of Government's right to the future performance of any such terms, Page - 14 - of 17 covenants or conditions and the Contractor's obligations in respect to such future performance shall continue in full force and effect.

4.8.8 Fire Prevention: The Contractor shall take all necessary precautions to prevent fires in the units and

Contractor-furnished and Government-furnished facilities while performing any work under this contract. In the event fires do occur, the Contractor shall immediately notify the Base Fire Department at 911. The Contractor shall then notify the requiring activity and the CO. The Contractor shall brief and document its employees monthly in fire safety issues and procedures in reporting fires.

4.8.9 Freedom of Information Act (FOIA): All official Government records affected by this contract are subject to the provisions of the FOIA (5 U.S.C. 552/DoD 5400.7-R/AF Supplement). Any request received by the Contractor for access/release of information from these records to the public (including Government/Contractor employees acting as private citizens), whether oral or in writing, shall be immediately brought to the attention of the CO for forwarding to the PACAF FOIA Manager to ensure proper processing and compliance with the Act.

4.8.10 For Official Use Only (FOUO): The Contractor shall comply with DoD 5400-7-R, Chapter 4, DoD

Freedom of Information Act (FOIA) Program requirements. This regulation sets policy and procedures for the disclosure of records to the public and for marking, handling, transmitting, and safeguarding FOUO material.

4.8.11 Hazardous Materials:

(1) Prior to use, the Contractor shall provide the Base Hazardous Material Pharmacy and 773 CES/CEANV, through the Contracting Officer, a list of all hazardous materials the Contractor brings onto Government property and shall submit and AF Form 3952 along with a Material Safety Data Sheet (MSDS) for each Hazardous Chemical listed in OSHA Hazard Communication Standard 29 CFR 1910.1200. The purpose of the inventory is to provide information to JBER for Emergency Planning and Community Right-to-Know Act (EPCRA) reporting.

(2) Any products that meet the criteria of “Hazardous Waste” must be bar coded and tracked until permanently removed from Government property. Criteria for identifying hazardous waste are contained in Subpart C of 40 CFR Part 261. NOTE: Products containing chlorofluorocarbons (CFC’s) or ozone depleting substances shall not be allowed or approved for use.

(3) The Contractor shall ensure that all Contractor employees complete the local Air Force

Hazardous Communication, HAZMart, and hazardous waste training. The Contractor shall appoint a primary and alternate HAZMART and Hazardous Waste monitor. Monitors are responsible for training all Contractor personnel regarding hazardous material containers maintained on JBER and complete MSDSs immediately upon receipt of new chemicals, products, or materials.

4.8.12 Inclement Weather: If the base closes due to inclement weather, the Contractor will be released with the general population of the base at no decrement to contract price. The Contractor will follow the local procedures for reporting in inclement weather as advertised on local television and radio stations.

4.8.13 Notification of Debarment/Suspension Status: The Contractor shall provide immediate notice to the

Contracting Officer in the event of being suspended, debarred or declared ineligible by any other Federal Department or agency, or upon receipt of a notice of proposed debarment from another DOD Agency, during the performance of this contract.

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4.8.14 Official Correspondence: The Government singularly identifies each project with a contract number at time of award. The contract number is a unique identifier to purposely and permanently represent an awarded project. The Government issued contract number is to be referenced on all official communication starting upon notice of award.

4.8.15 Past Performance Information (PPI) / Contractor Performance Assessment Report (CPARS): The

Government will formally assess and report on the Contractor’s performance annually. CPARS assesses a contractor’s performance, both positive and negative, and provides a record on a given contract during a specified period of time. The Contractor will be provided a copy of their annual assessment at the end of each performance period. The Contractor shall have 30 days to review and submit comments for the evaluation activity’s consideration before the assessment is made final.

Past Performance assessment reports will be protected by all parties and treated by Government personnel as “For Official Use Only/Source Selection Information in accordance with FAR 2.101 and 3.104”.

4.8.16 Privacy Act: Work on this contract may require that personnel have access to information protected by the Privacy Act. Contractor personnel shall adhere to the Privacy Act, Title 5 of the U.S. Code, Section 552a and applicable agency rules and regulations when handling such information.

4.8.17 Records: All records created and received by the Contractor in the performance of this contract shall be maintained and readily accessible. Records shall remain the property of the Government.

4.8.18 Safety Concerns: The Contractor is solely responsible for compliance with OSHA standards for the protection of their employees. The contract manager shall ensure specific safety requirements in AFOSH standards and Air Force technical orders are complied with by Contractor personnel when non- compliance would clearly present the potential to harm or damage Government resources. (See AFI 91- 301, paragraph 9 and AFI 21-101 paragraph 2.16.) The Air Force is not responsible for ensuring that Contractors comply with “personal” safety requirements that do not present the potential to damage Government resources.

4.8.19 Section 508 Compliance: The Contractor shall support the Government in its compliance with

Section 508 throughout the development and implementation of the work to be performed. Section 508 of the Rehabilitation Act of 1973, as amended (29 U.S.C. 794d) requires that when Federal agencies develop, procure, maintain, or use electronic information technology, Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who do not have disabilities, unless an undue burden would be imposed on the agency. Section 508 also requires that individuals with disabilities, who are members of the public seeking information or services from a Federal agency, have access to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities, unless an undue burden would be imposed on the agency.

4.8.20 Subcontracting: The Contractor shall ensure that any subcontractor providing services on behalf of the Contractor has been approved by the Contracting Officer prior to any such performance. The subcontractor shall not have a negative performance history or be suspended or otherwise prohibited from doing business with the Government.

4.8.21 Weapons, Firearms, and Ammunition: Contractor employees are prohibited from possessing weapons, firearms, or ammunition on themselves or within their Contractor-owned privately owned vehicles while on JBER.

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SECTION V

APPENDIX 1

5.0 DEFINITIONS:

Contract Administrator (CA). The individual within the contracting office who performs the day-to-day administration of the contract. The contract administrator may also be the contracting officer.

Contracting Officer (CO). The duly appointed Government agent authorized to award or administer contracts. The contracting officer is the only person authorized to contractually obligate the Government.

Government Furnished Property (GFP). Facilities, equipment, tools, supplies, parts, or any other items furnished for the concessionaire's use by the Government.

Performance Assessment. A process that measures success towards achieving defined performance objectives or goals defined within the performance thresholds in the services summary or the process of assessing progress towards achieving the objectives/goals developed in a performance plan or partnering agreement.

Performance Indicator. A measurable characteristic of an output of a work process. Generally synonymous with attribute.

Performance Objective. The outcome associated with successful contract performance in a specific area.

This is a critical success factor in achieving the organization’s mission, vision and strategy which, if not achieved, would likely result in a significant decrease in customer satisfaction or risk mission failure.

Obtaining multi-services/sub-services performed at a certain measurable standard and consistently ensures success in achieving the objectives critical to the mission.

Performance Threshold. The minimum performance level of a performance objective required by the Government.

Surgical Instrument Quality Assurance Personnel (QA or QAP). Individual who monitors a Contractor on a daily basis and who is involved in every aspect of a contract to ensure the Contractor is in compliance with that contract.

Services Summary (SS). A summary of the performance objective and performance threshold required by the Government in concessionaire performance. Also known as a Performance Requirements Summary or Services Delivery Summary or Performance Requirements Document.

Standard. An exact value, a physical entity, or an abstract concept, established and defined by authority, custom, or common consent to serve as a reference, model, or rule in measuring quantities or qualities, establishing practices or procedures, or evaluating results. A fixed quantity or quality. A defined measure of comparison.

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5.1 ACRONYMS:

AAMI American Association of Medical Instrumentation AFI Air Force Instruction ASQ American Society for Quality COR Contracting Officer Representative COTR Contracting Officer Technical Representative CQI Certified Quality Inspector DoD Department of Defense IAHCSMM International Association of Healthcare Central Service Materiel Management IFU Instructions for Use JBER Joint Base Elmendorf-Richardson JC Joint Commission MIS Minimally Invasive Surgery OR Operating Room PACAF Pacific Air Force PM Preventive Maintenance QCP Quality Control Plan SIQAP Surgical Instrument Quality Assurance Program SPD Sterile Processing Department