TMDE PWS June 2020.pdf

PERFORMANCE WORK STATEMENT

(PWS)

For

PREVENTATIVE MAINTENANCE AGREEMENT

BIOMEDICAL TEST EQUIPMENT

MAINTENANCE

633D MEDICAL GROUP, JOINT BASE LANGLEY-EUSTIS, VIRGINIA

(NON-PERSONAL SERVICE)

15 June 2020

TABLE OF CONTENTS

TITLE

DESCRIPTION OFSERVICES

GENERAL INFORMATION

SERVICES SUMMARY

APPENDIX

1 APPLICABLE PUBLICATIONS AND FORMS

2 TERMS

3 CONTRACT MAINPOWER REPORT

4 HEALTH INSURANCE PORTABILITY AND

ACCOUNTABILITY ACT (HIPAA) OF 1996

5 EQUIPMENT INFORMATION

PAGE

s

IS

PERFORMANCE WORK STATEMENT (PWS)

For

BIOMEDICAL TEST EQUIPMENT

MAINTENANCE

SECTION 1

1.0. SCOPE OF WORK. The contractor shall furnish all labor, tools, parts, materials, facilities, and transportation necessary to provide preventive maintenance and calibration for all equipment listed in Appendix 5. The equipment is currently located at the United States Air Force (USAF) Hospital, 633d Medical Group (633 MDG), Joint Base Langley-Eustis (JBLE), Virginia, Langley AFB division, also referred to as the Military Treatment Facility (MTF) herein. All labor necessary to perform calibration, installation of replacement parts, other servicing of equipment, and travel time shall be included in the contractor's pricing to maintain the systems and ancillary equipment.

1.0.1. REQUESTS FOR SERVICE. Only the Contracting Officer (CO), Contracting Officer Representative (COR), Functional Requirements Evaluator Designee (FRED) or Medical Maintenance personnel are authorized to place requests for service on this contract.

1.1. DESCRIPTION OF SERVICES

1.1.1. Preventive Maintenance Inspections, (PMI).

1.1.1.1. The contractor shall provide one (1) or two (2) PMls per year for each separate unit depending on the manufacturer's specifications. There should be one (1) on-site PMI per year.

The contractor shall schedule PMI 15 days in advance with the CORI Medical Maintenance department. Preventive maintenance shall be performed during normal hours of coverage, (0730-1630) between the 1st and the 25th day of the month of April. PMI service shall be performed to ensure that the equipment performs in accordance with manufacturer's conformance standards.

1.1.1.2. For the items not capable of being inspected during the on-site PMI, the contractor will ensure the items are inspected by a valid inspection authority during the maintenance cycle they are currently on. This will include providing shipment labels and coordinating any return materials authorizations (RMAs) required.

1.1.2. The contractor shall provide and utilize procedures and checklists with worksheet originals indicating work performed and actual values obtained (as applicable) and provide them to the COR/FRED in the Medical Maintenance department at the completion of the PMI.

1.1.3. PM services shall, as a minimum, include the system services at the frequencies recommended by the original equipment manufacturer (OEM).

1.1.3.1. The PM system services must include, but are not to be limited to:

1.1.3.1.1. Calibrate and lubricate the equipment.

1.1.3.1.2. Perform remedial maintenance of a non-emergency nature.

1.1.3.1.3. Test and replace faulty and worn parts and/or parts which are likely to become faulty, fail, or become worn before the next PMI. This will be at no additional cost to the government.

1.1.3.1.4. Inspect for wear and fraying, and replacing where necessary, electrical wiring, cables, high voltage cables, bushings and dielectric, as necessary.

1.1.3.1.5. Measure, adjust and calibrate as necessary for optimal image quality.

1.1.3.1.6. Inspect and replacing where indicated, all mechanical components including, but not limited to, patient restraints and support devices; cables and mounting hardware; chains, belts, bearings and tracks; interlocks, clutches, motors, and keyboards for mechanical integrity, safety, and performance.

1.1.3.1.7. Inspect output devices, e.g. monitors, laser imagers, cameras and processors. Calibrate or recommend calibration, if appropriate.

1.1.3.1.8. Return the equipment to the operating condition defined by the original equipment manufacturer's specifications.

1.1.3.1.9. Provide service report of services performed.

1.1.3.2. All exceptions to the PM schedule must be arranged in writing and approved in advance by the CO/COR.

1.1.3.3. The contractor shall provide all OEM parts, services, manuals, tools, instrumentation, or software required to successfully complete scheduled PM is.

1.1.4. Calibration Services.

1.1.4.1. The contractor shall provide one on-site calibration per year, with the calibrations occurring at the same time as the PMI's. Equipment not capable of being calibrated on-site will be calibrated in accordance with manufacturer specifications.

1.1.4.2. Equipment not calibrated on-site will be shipped to contractor for PMI and calibration within the first 1O days of the month. Equipment should then be mailed from contractor by the 25 of the same month.

1.1.5. Service Manuals.

1.1.5.1. The government will not provide service manuals or service diagnostic software to the contractor. The contractor shall be responsible for providing all service manuals, operational manuals, schematics, and diagnostic software necessary to maintain the required system up-time to the contractor's field service representative(s).

1.1.6. Updates. The contractor shall provide all updates, to include: installing manufacturer designed and issued field modifications, safety corrections and revisions for correcting software and equipment deficiencies at no additional cost to the government. Upgrades and modifications shall be furnished at no additional cost under the contract and installed during the PMIs after the manufacturer makes them available. Updates shall not include those designed primarily as performance enhancements or performance upgrades.

1.1.7. Conformance Standards. The contractor shall keep the system in good operating condition, meeting all equipment and performance requirements published by the OEM. The contractor assumes responsibility for system conformance with the latest published edition of National Fire Protection Association (NFPA) 99, Occupational Health and Safety Administration (OSHA), and Center for Devices and Radiological Health (CDRH) standards.

1.2. GENERAL INFORMATION

1.2.1. Personnel.

1.2.1.1. Point of Contact. The contractor shall provide a primary, and alternate, point of contact in writing, at time of contract award, with full authority to interface with the government representative or CO on all contract matters relating to the daily operations. Contractor shall provide a list with names, addresses and phone numbers of personnel to be on site within 15 days of contract start date. If the primary point of contract should change, the contractor shall, within 15 calendar days of the change, notify the CO in writing.

1.2.2. Contractor's field service representatives shall be able to read, write, speak and understand English. Contractor personnel shall display legible identification of the contractor company's name.

1.2.3. Qualifications/Education/training.

1.2.3.1. Prior to award of the contract and each subsequent performance period, the contractor shall certify to the FRED that the field service representative has had professional formal training on equipment specific to this contract, and at least annual continuing education, to include OEM specific training.

1.2.3.2. If the training occurred more than three years ago, proof of recent (during past 18 months) maintenance experience on specified equipment must be provided.

1.2.3.3. The FRED/Medical Maintenance department may at any time request verification of service personnel credentials who are servicing the equipment from the contractor.

1.2.4. Administrative Control.

1.2.4.1. Service Call Log.

1.2.4.1.1. The contractor shall report to the Medical Maintenance department, building 257 room IE054A, and sign-in on the contractor service log with the FRED/Medical Maintenance department prior to reporting to the work-site.

1.2.4.1.2. Upon completion of each PMI, calibration, or corrective service call, the contractor shall provide a signed system maintenance record to the FRED/Medical Maintenance department.

1.2.4.1.3. The FRED/Medical Maintenance department will countersign the report to certify that the services were rendered. At this time, the contractor shall sign-out on the contractor service log.

1.2.4.1.4. The government will not recognize any maintenance actions that have not been signed by the FRED/Medical Maintenance department.

1.2.4.1.5. All maintenance documents shall be prepared and validated in duplicate. The FRED/Medical Maintenance department and the contractor shall each retain a copy.

1.2.5. Documentation and reporting shall be in compliance with the Joint Commission standards.

1.2.5.1. The System Maintenance Record for each PMI or service call will include at minimum:

1.2.5.2. Name of the contractor.

1.2.5.3. Name of the contractor's field service representative.

1.2.5.4. Date, time (starting and ending), equipment downtime, and hours-on-site. The contractor's field service representative must report to the Medical Maintenance department in accordance with local guidelines.

1.2.5.5. Itemized description of service performed (including labor, parts, and corrective action taken).

1.2.5.6. Identification of equipment to include equipment control number, manufacturer, device, model number, and serial number.

1.2.6. Billing Procedures. This service contract shall be billed monthly, in arrears. The contractor's invoice shall reflect the following information:

1.2.6.1. Invoice number

1.2.6.1.1. Contract/purchase order number.

1.2.6.1.2. Billing period.

1.2.6.1.3. Amount in American dollars.

1.2.6.1.4. Manufacturer, model and serial number of each piece of equipment serviced with documentation of work performed or part(s) provided.

1.2.6.1.5. Invoices shall be submitted in accordance with (IAW) wide area workflow (WAWF) procedures.

1.2.6.1.6. Certification of payment will not be accomplished until all required service documents have been received by the FRED/Medical Maintenance department for the payment period.

1.2.7. Claims of government misuse or abuse. If the contractor claims any service calls are the result of government abuse or misuse, the damage shall immediately be shown on the system maintenance record. Verified by the FRED/Medical Maintenance department, and approved by the CO before repairs are made. The CO will resolve disagreements as to responsibility between both parties.

1.2.8. Reporting required services beyond the scope of contract. The contractor shall immediately, but not later than 24 consecutive hours after discovery, notify the CO and FRED or Medical Maintenance department in writing of the existence or the development of any defects in, or repairs required to the scheduled equipment for which the contractor considers he/she is not responsible under the terms of the contract. The contractor shall furnish the CO and FRED/Medical Maintenance with a written estimate of the cost to make necessary repairs, and a full technical description, prior to the commencement of work.

1.2.8 1. Additional charges. There shall be no additional charge for time spent at the site awaiting the arrival of additional contractor personnel and/or delivery of parts.

1.2.9. Safety. The contractor shall comply with American OSHA Standards, and Air Force safety standards at all times while on government property. Safe working practices shall be followed.

Requirements include, but are not limited to:

1.2.9.1. The government's use of lock-out/tag-out procedures while working on electrical systems and equipment.

1.2.9.2. Report any injuries to contracted employees or damage to government equipment to the COR/Medical Maintenance department at 757-764-6785, immediately.

1.2.10. Security Requirements. The contractor shall be responsible for safeguarding all government property and controlled items provided for contractor use. At the end of each work period, all government facilities, equipment, and materials shall be secured by government personnel. Contractor personnel shall not be issued keys to any facilities by government personnel.

1.2.11. Performance of Services during Labor Strikes. If the contractor personnel are under a Collective Bargaining Agreement, the contractor shall submit an emergency strike plan no later than ten (10) workdays after start of contract.

1.2.12. Smoking in Air Combat Command (ACC) Facilities. Contractors and/or contractor personnel are advised that the ACC Commander has placed restrictions on the smoking of tobacco products in ACC facilities. AFI 40-102, Tobacco Use in the Air Force (current edition), outlines the procedures used by the commander to control smoking in our facilities. Contractors, contractor personnel and visitors are subject to the same restrictions as government personnel.

Smoking is permitted only in designated smoking areas.

1.2.13. Traffic Laws. The contractor and/or contractor personnel shall comply with the installation traffic code as specified in Virginia State Law and Langley Air Force Base Instruction (LAFBI) 31-204, Langley Air Force Base Traffic Code (current edition). The contractor and/or contractor personnel shall comply with current instruction on cell phone use while on a military installation.

1.2.14. Weapons, Firearms, and Ammunition. The contractor and/or contractor personnel is/are prohibited from possessing weapons, firearms, or ammunition, on themselves or within their contractor-owned vehicle or privately-owned vehicle while on any Air Force base.

SECTI0N2

2.0. SERVICES SUMMARY (SS). The contractor service requirements are summarized in performance objectives that relate directly to mission essential items. The performance threshold briefly describes the minimal acceptable levels of service required for each requirement. The SS and the contractor's Quality Control Plan (QCP) provide information on contract requirements, the expected level of the contractor's performance and the expected method of government surveillance and confirmation of services provided. These thresholds are critical to mission success. Procedures as set forth in the Federal Acquisition Regulation (FAR) 52.212-4 (a), Contract Term is and Conditions - Commercial Items, Inspection/Acceptance, will be used to remedy all deficiencies.

The absence of any contractor requirements from the SS shall not detract from its enforceability nor limit the rights or remedies of the government under any other provision of the contract, including the clauses entitled "Inspection of Services" and "Default." The government has the right to inspect all services required in the contract.

Performance Objective/Service Summary Item # PWS Para

Performance Threshold Surveillance

SS# I - Contractor performs scheduled maintenance on all specified test equipment.

1.1.1., 1.1.2., 1.1.3.

Appendix

100% Periodic Surveillance

Customer Complaint

SS#2 - The contractor shall provide one on-site calibration per year, with the calibrations occurring at the same time as the PMI's. Equipment not capable of being calibrated on-site will be calibrated in accordance with manufacturer specifications.

1.1.4.1. 100% Periodic Surveillance

SS#3-Equipment not calibrated on-site will be shipped to contractor for PMI and calibration within the first 10 days of the month. Equipment should then be mailed from contractor by the 25th of the same month.

1.1.4.2 95% Periodic

Customer

Complaint

SS#4 - The government will not provide service manuals or service diagnostic software to the contractor. The contractor shall be responsible for providing all service manuals, operational manuals, schematics, and diagnostic software necessary to maintain the required system up-time to the contractor's field service representative(s).

1.1.5.1. 95% Periodic Surveillance

SS#5 - Updates. The contractor shall provide all updates.

to include: installing manufacturer designed and issued field modifications, safety corrections and revisions for correcting software and equipment deficiencies at no additional cost to the government. Upgrades and modifications shall be furnished at no additional cost under the contract and installed during the PM is after the manufacturer makes them available. Updates shall not include those designed primarily as performance enhancements or performance upgrades.

1.1.6. 100% Periodic

2.1. Performance Evaluation. The purpose of the SS is to define performance evaluation. The Performance Objective (column 1) describes what the government will survey. Performance of a service will be evaluated to determine whether or not it meets the Performance Threshold (PT) of the contract. When the PT is exceeded, the COR will document the file with a Corrective Action Report (CAR) or a Performance Assessment Report (PAR) and forward these documents to the CO for their determination if further action is necessary.

2.1.1. The government will periodically evaluate the contractor's performance throughout the life of the contract by appointing a representative(s) to monitor performance to ensure services are received. The government representative will evaluate the contractor's performance through inspections of reports and contract services documentation. The government may inspect each task as completed or increase the number of quality assurance inspections if deemed appropriate because of repeated failures. Likewise, the government may decrease the number of quality assurance inspections if performance dictates.

2.1.2. If any of the services do not conform to contract requirements, the government may require the contractor to perform the services again in conformity with contract requirements at no increase in contract amount. When the defects in services cannot be corrected by re-performance, the government may:

2.1.2.1. Require the contractor to take necessary action to ensure the future performance conforms to contract requirements.

2.2. Quality Control. A description of how records will be kept. Records must document all inspections and corrective or preventive actions taken. A written report out lining all service and parts used shall be provided upon work completion.

2.3. Quality Assurance. The government will inspect and evaluate the contractor's performance to ensure services are received in accordance with (IAW) requirements set forth in this contract.

The FRED shall inspect by watching actual task performance, physically checking an attribute of the completed task, checking a management information report, investigating customer complaint's, conferring with facility managers, or otherwise inspecting the task or its results to determine whether or not performance meets the standards contained in this PWS. Only one (I) method will be used at a time to evaluate a listed service during an inspection period for payment computation purposes. The COR will record surveillance results. Results of the surveillance then become the official Air Force record of the contractor's performance. When a performance threshold has not been met or contractor performance has not been accomplished, the COR will initiate and provide the CO with a CAR or a Contract Discrepancy Report (CDR) for issuance to the contractor. The contractor shall respond to the report IA W instructions provided and return it to CO within ten (1 0) calendar days of receipt.

2.4. Surveillance Methods.

2.4.1. 100 Percent Inspection. This method requires the COR to request the service each time it occurs. The FRED will use the Quality Assurance Surveillance Checklist (QASC) during inspection. The FRED's inspection will be on items identified in the Services Summary as 100% Inspection as the Method of Surveillance and the results of the inspection will be documented on the checklist. Any deficiency shall be documented and the contractor shall re-perform service immediately, if appropriate, or within 24 hours at no increase in contract amount. Any unsatisfactory inspection identified but re-performed acceptably shall still be counted as an unsatisfactory inspection for trending purposes.

2.4.2. Periodic Surveillances. This method requires the FRED to employ a "spot check" style of evaluation based on the contractor's schedule. Periodic surveillances will be conducted on a scheduled basis (daily, weekly, monthly, quarterly, semi-annual or annually) and may be adjusted, based on quality trends. Any unsatisfactory inspection (defect) result shall be recorded, and the contractor shall re-perform the service after notification by the FRED.

2.4.3. Customer Complaint. This method requires the customer to fill out a Customer Complaint Record (CCR) or a locally generated form provided by the FRED or CO. The FRED will verify the complaint and notify the contractor of valid complaints. The contractor shall acknowledge the complaint within eight (8) hours and inform the FRED of its recommendation. Any deficiency shall be documented and the contractor shall re-perform service immediately, if appropriate, or within 48 hours at no increase in contract amount. The contractor shall respond to the Customer Complaint in accordance with the instructions provided and return it to the contracting office within five (5) calendar days of receipt. Any unsatisfactory inspection identified but re-performed acceptably shall still be counted as an unsatisfactory inspection.

2.4.3.1. Customer Complaint Standards.

2.4.3.1.1. Failing to meet the performance threshold as outlined in the SS for any of these performance objectives in any one month period shall constitute an immediate Progress Meeting with the Multi-Functional Team.

2.4.3.1.2. Failing to meet the performance threshold as outlined in the SS of these performance objectives in any combination for any two, or more consecutive or non-consecutive months during a contract period shall result in a warning or letter of concern from the CO.

2.4.3.1.3. All remedies shall be in accordance with the FAR 52.212-4 (a), Contract Terms and Conditions - Commercial Items, Inspection/Acceptance.

2.5. Performance Evaluation/Periodic Progress Meetings. The CO, contract administrator, Functional Commander, COR, other government personnel as appropriate, and the contractor shall periodically meet to discuss the contractor's performance. The contractor may request a meeting with the CO when deemed necessary.

2.5.1. The following issues shall be discussed: opportunities to improve the contract; any modifications required of the contract; unsatisfactory inspections and trends against each performance objective; observed positive performance; and steps taken by the contractor to prevent unsatisfactory occurrences in the future. The contractor shall provide a summation of unsatisfactory inspections and customer complaints and provide insight into any identified trends.

2.5.2. Meetings will be documented in the contract file with written minutes signed by the CO, the contractor and any other signatures as deemed appropriate. The signed minutes will be distributed to the functional area and the contractor.

2.5.3. Should the contractor not concur with the minutes, the contractor shall provide a written response to the CO within ten ( I 0) calendar days of receipt of the minutes identifying areas of non-concurrence for resolution.

2.6. Government Receipt and Acceptance of Goods.

2.6.1. Wide Area Work Flow. The service contract manager (SCM) will certify receipt of contractor services via the Wide Area Work Flow (WAWF) website. Certification of services will be accomplished using the contractor's combination invoice/receiving report following the completion of the contract payment period.

2.6.2. All work requirements shall be completed and accepted by the COR prior to any payments being made for services performed during the month.

APPENDIX I

DEPARTMENT OF DEFENSE and AIR FORCE PUBLICATIONS

Publications and forms applicable but not all inclusive to the PWS are listed below. The contractor is obligated to follow those publications. These publications are available in the MTF and maintained by the government. Supplements or amendments to listed publications from any organizational level may be issued during the life of the contract. The contractor shall immediately implement those changes in publications which may result in a decrease or no change in the price and notify the CO in writing of such change. Should a decrease in contract price result, the contractor shall provide a proposal for reduction in the price to the CO. Prior to implementing any change that will result in an increase; the contractor shall submit to the CO a price proposal within 30 calendar days of receipt of the change by the contractor. The CO and the contractor shall negotiate the change into the contract under the provisions of the FAR clause 52.212-4(c) entitled "Changes". Failure of the contractor to submit a price proposal within 30 calendar days from receipt of the change shall entitle the government to receive performance IAW such change at no increase in price.

DEPARTMENT OF DEFENSE and AIR FORCE PUBLICATIONS:

AIR FORCE INSTRUCTIONS (AFI)

PUB NO. TITLE DATE

AFI 31-501 Personal Security Program Management Jan OS

AFI 33-100 User Responsibilities and Guidance for Information Systems Nov08

AFI 33-119 Air Force Messaging Jan05

AFI44-119 Medical Quality Operations Sep07

PUB NO. CHANGE

DoD 5200.2R

DoD 6025.18R

DoDD 5400.11 DoD Privacy Program May

DoDD 5500.07 Standards of Conduct Nov

DoDI 1402.5 Criminal History Background Checks on Individuals in Child Care Services Jan 93

DoD 8580.02R HIPAA Security Rule Jul 07

DEPARTMENT OF DEFENSE (DoD)

TITLE DATE

Ch 1, Feb 90

DoD Personnel Security Program Jan 87 Ch 2, Jul 93 C3, Feb 96

DoD Health Information Privacy Regulation Jan03

OTHER REFERENCES

The Joint Commission (TJC) (formerly the Joint Commission on Accreditation of Healthcare Oreanizations (JCAHO)) Accreditation Manual http://www.jointcommission.org/

APPENDIX2

The following terms shall have the meaning set forth in this contract (if applicable):

BILLABLE HOUR: A billable hour is identified as a duty hour or an overage hour. A billable hour can only be billed to the government if the contractor personnel provide services at the place of performance as required in the work schedule.

CERTIFICATION: Official recognition by a national agency or association that the contractor personnel has successfully completed an approved education program or evaluation process.

This includes formal processes designed to assess the knowledge, experience, skills, and abilities required to provide quality patient care.

COMMANDER: MTF Commander, Flight Commander, or designated representative (e.g., Quality Assurance Personnel), or Department Head of the activity designated in a particular task order.

CONTRACTING OFFICER (CO): The individual with authority to enter into, administer, or terminate contracts ( FAR 1.603-1).

CONTRACTING OFFICER'S REPRESENTATIVE (COR): Individuals designated to perform quality assessment functions. They serve as on-site technical managers assessing contractor performance against contract performance standards.

CONTRACTOR: The contractor is an independent contractor and responsible for its own liability.

Contractor refers to the prime contractor. The prime contractor retains responsibility for any teaming partner or subcontractor and shall be accountable for their performance.

CONTRACTOR MANAGEMENT STAFF: The contractor's internal staff, including all teaming partners, subcontractors, and their staff at corporate level involved in the company's or team's administration of this contract.

CURRENT COMPETENCE: The state of having adequate knowledge, skills, ability, and behaviors to perform the functions of a provider in a particular discipline.

DOWN DAYS: Any day the Air Force leadership designates as a minimal manning/liberal leave day for government employees.

DUTY DAY: A day in which the contractor personnel is scheduled to be present for work on the work schedule.

DUTY HOURS: The number of billable hours in a duty day on the work schedule. A duty hour is billable to the government whenever the contractor personnel is required to and performs work IAW the work schedule at the place of performance.

FUNCTIONAL REQUIREMENTS EVALUATOR DESIGNEE {FRED}: Individuals designated to perform quality assessment functions. They serve as on-site technical managers assessing contractor performance against contract performance standards.

MILITARY TREATMENT FACILITY (MTF}: Air Force hospitals, clinics or logical extensions such as Health and Wellness Centers, to include all activities providing outpatient and/or in-patient healthcare services for authorized personnel.

ORDERING CONTRACTING OFFICER: The Contracting Officer executing task orders.

PERFORMANCE WORK STATEMENT (PWS): The standard of work that describes the core requirements in clear, specific, and objective terms with measurable outcomes.

QUALIFIED: Refers to contractor personnel meeting the minimum requirements on the contract including, but not limited to, preliminary government minimum requirements and subsequent government minimum requirements.

QUALIFYING DOCUMENTATION: The credentials required by the government to ensure the contractor personnel meets the preliminary government minimum requirements (i.e., education, experience, certification, licensure, and initial background check) and subsequent government minimum requirements (i.e., health, immunizations, credentialing, complete background check, drug screen, and security) established in the performance work statement and the task order.

QUALITY CONTROL (QC): Those actions taken by a contractor to control the quality of output and to ensure they conform to contract requirements and reasonable standards of medical care.

RECRUIT: The contractor's process to find, conduct preliminary screening, and obtain initial background checks to submit qualifying documentation on contractor personnel willing to provide services for specific positions at the required place of performance.

REPLACEMENT: The permanent change of qualified contractor personnel with another qualified contractor personnel.

SERVICES SUMMARY (SS): Sets the critical performance objectives in the contract and prescribes how the government plans to assess contractor performance.

SUBSTITUTION: The temporary placement of qualified contractor personnel for a defined period of time when the permanent contractor personnel will return to work.

UNPLANNED CLOSURE: The closure of a federal facility due to natural disasters, military emergency, severe weather, or any other reason that is not planned.

APPENDIX3

CONTRACT MANPOWER REPORT

1. CONTRACTOR MANPOWER REPORTING. The contractor shall provide a Contractor Manpower Report IAW the Secretary of the Air Force/Acquisition (SAFIAQ), 13 Nov 12 Letter, Implementation of Fiscal Year (FY).11 National Defense Authorization Act (NDAA) Section 8108, Contractor Inventory. Contract Manpower Report should contain the following:

2. AUTHORITATIVE REFERENCE. SAF/AQ Letter 13 Nov 12 (Implementation of FYI I NOAA Section 8108, Contractor Inventory.

3. FORMAT. Format shall be narrative as determined by the contractor.

4. CONTENT. The report shall include the following:

"The contractor shall report ALL contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract for the ADVANCED STERILIZATION PRODUCTS EVOTECH AND STERRAD NX REPAIR PMA Services via a secure data collection site. The contractor is required to completely fill in all required data fields at http://www.ecmra.mil."

"Reporting inputs shall be for the labor executed during the period of performance for each government fiscal year (FY), which runs 1 October through 30 September. While inputs may be reported any time during the FY, all data shall be reported no later than 31 October* of each calendar year. Contractors may direct questions to the CMRA help desk."

*Reporting Period: Contractors are required to input data by 31 October of each year.

Uses and Safeguarding of Information: Information from the secure web site is considered to be proprietary in nature when the contract number and Contractor identity are associated with the direct labor hours and direct labor dollars. At no time will any data be released to the public with the Contractor name and contract number associated with the data.

User Manuals: Data for Air Force service requirements must be input at the Air Force CMRA link. However, user manuals for Government personnel and Contractors are available at the Army CMRA link at http://www.ecmra.mil.

http://www.ecmra.mil/ http://www.ecmra.mil/

APPEND1X4

HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT

(HIPAA) OF 1996

HIPAA is comprised of several different sections, each to be implemented by the Dept. of Health and Human Services. The AFMS and its components are specifically listed as covered entities (CE) under HIPAA. Currently, HIPAA Privacy and Security Rules, as set forth in the Code of Federal Regulations, are in effect for all AFMS CEs. The specific implementation of HIPAA Privacy for DOD medical facilities is set forth in DOD 6025.18-R, and for HIPAA Security, the requirements for the AFMS are contained in AFI 41-217, which also contains additional Information Assurance requirements. Both DOD 6025.18-R and AFI 41-217 are incorporated herein by reference. AFMS organizations are responsible to insure overall compliance with HIPAA requirements, which includes incorporation of certain requirements in contracts entered or amended after the respective implementation dates.

IAW DoD 6025.18-R. the contractor and its employees meet the definition of Business Associate.

Therefore, a Business Associate Agreement is required by law to comply with both the HIPAA Privacy and Security regulations. This clause serves as that agreement for this contract/BAA, whereby the contractor and its employees agree to abide by all HIPAA Privacy and Security requirements regarding health information as defined in this clause, DoD 6025.18-R, and AFI 41-217. Additional HIPAA requirements will be addressed when implemented.

Introduction

(a) Definitions. As used in this clause generally refer to the Code of Federal Regulations (CFR) definition unless a more specific provision exists in DOD 6025.18-R or AFI 41-217.

Individual has the same meaning as the term "individual" in 45 CFR 164.50 1 and 164.103 and shall include a person who qualifies as a personal representative in accordance with 45 CFR 164.502(g)

Privacy Rule means the Standards for Privacy of Individually Identifiable Health Information at 45 CFR part 160 and part 164, subparts A and E.

Protected Health lnfon11atio11 has the same meaning as the term "protected health information" in 45 CFR 164.50 I, limited to the information created or received by the contractor from or on behalf of the government.

Electronic Protected Health lnfon11ation has the same meaning as the term "electronic protected health information" in 45 CFR 160.103.

Required by Law has the same meaning as the term "required by law" in 45 CFR 164.50 I and 164.103.

Secretary means the Secretary of the Department of Health and Human Services or his/her designee.

Security Rule means the Health Insurance Reform: Security Standards at 45 CFR pan 160,l62 and pan 164, subpart C.

Terms used, but not otherwise defined, in this Agreement shall have the same meaning as those terms in 45 CFR 160.103, 164.501 and 164.304.

(b) The contractor agrees to not use or further disclose Protected Health Information other than as permitted or required by the Contract or as Required by Law.

c) The contractor agrees to use appropriate safeguards to prevent use or disclosure of the Protected Health Information other than as provided for by this Contract.

(d) The contractor agrees to use administrative, physical, and technical safeguards that reasonably and appropriately protect the confidentiality, integrity, and availability of the electronic protected health information that it creates, receives, maintains, or transmits in the execution of this Contract.

(e) The contractor agrees to mitigate, to the extent practicable, any harmful effect that is known to the Contractor of a use or disclosure of Protected Health Information by the contractor in violation of the requirements of this contract.

(/) The contractor agrees to report to the government any security incident involving protected health information of which it becomes aware. ·

(g} The contractor agrees to report to the government any use or disclosure of the Protected Health Information not provided for by this contract of which the contractor personnel becomes aware of.

(h) The contractor agrees to ensure that any agent, including a subcontractor, to whom it provides Protected Health Information received from, or created or received by the contractor on behalf of the government, agrees to the same restrictions and conditions that appJy through this contract to the contractor with respect to such information.

(i} The contractor agrees to ensure that any agent, including a subcontractor, to whom it provides electronic Protected Health Information, agrees to implement reasonable and appropriate safeguards to protect it.

(j) The contractor agrees to provide access, at the request of the government, and in the time and manner designated by the government to Protected Health Information in a Designated Record Set, to the government or, as directed by the government, to an Individual in order to meet the requirements under 45 CFR 164.524.

(k) The contractor agrees to make any amendment(s) to Protected Health Information in a Designated Record Set that the government directs or agrees to pursuant to 45 CFR 164.526 at the request of the government or an Individual, and in the time and manner designated by the government.

(1) The contractor agrees to make internal practices, books, and records relating to the use and disclosure of Protected Health Information received from, or created or received by the contractor on behalf of, the government. available to the government, or at the request of the government to the Secretary, in a time and manner designated by the 'government or the Secretary, for purposes of the Secretary determining the government's compliance with the Privacy Rule.

(m) The contractor agrees to document such disclosures of Protected Health Information and information related to such disclosures as would be required for the government to respond to a request by an Individual for an accounting of disclosures of Protected Health Information in accordance with 45 CFR 164.528.

(n) The contractor agrees to provide to the government or an Individual, in time and manner designated by the government, information collected in accordance with this Clause of the Contract, to permit the government to respond to a request by an Individual for an accounting of disclosures of Protected Health Information in accordance with 45 CFR 164.528.

General Use and Disclosure Provisions

Except as otherwise limited in this Agreement, the contractor may use or disclose Protected Health Information on behalf of, or to provide services to, the government for treatment, payment, or healthcare operations purposes, in accordance with the specific use and disclosure provisions below, if such use or disclosure of Protected Health Information would not violate the Privacy Rule, the Security Rule or DOD 6025.ISR if done by the government.

Specific Use and Disclosure Provisions

(a) Except as otherwise limited in this Agreement, the contractor may use Protected Health Information for the proper management and administration of the contractor or to carry out the legal responsibilities of the contractor.

(b) Except as otherwise limited in this Agreement, the contractor may disclose Protected Health Information for the proper management and administration of the contractor, provided that disclosures are required by law, or the contractor obtains reasonable assurances from the person to whom the information is disclosed that it will remain confidential and used or further disclosed only as required by law or for the purpose for which it was disclosed to the person, and the person notifies the contractor of any instances of which it is aware in which the confidentiality of the information has been breached.

(c) Except as otherwise limited in this Agreement, the contractor may use Protected Health Information to provide Data Aggregation services to the government as permitted by 45 CFR 164.504(e)(2)(i)(B).

(d) Contractor may use Protected Health Information to report violations of law to appropriate Federal and State authorities, consistent with 45 CFR I64.502(j)( 1).

Obligations of the Government

Provisions for the Government to lnfonn the Contractor of Privacy Practices and Restrictions

(a) Upon request the government shall provide the contractor with the notice of privacy practices tha the government produces in accordance with 45 FR 164.520, as well as any changes to such nouce.

(b) The government shall provide the contractor with any changes in, or revocation of, permission by Individual to use or disclose Protected Health Information, if such changes affect the contractor's permitted or required uses and disclosures.

(c) The government shall notify the contractor of any restriction to the use or disclosure of Protected Health Information that the government has agreed to in accordance with 45 CFR 164.522.

Permissible Requests by the Government

The government shall not request the contractor to use or discJose Protected Health Information in any manner that would not be permissible under the Privacy Rule if done by the government, except for providing Data Aggregation services to the government and for management and administrative activities of the contractor as otherwise permitted by this clause.

Termination

(a) Termination. A breach by the contractor personnel of this clause, may subject the contractor to termination under any applicable default or termination provision of this contract.

(b) Effect of Termination.

(1) If this contract has records management requirements, the records subject to the Clause should be handled in accordance with the records management requirements. If this contract does not have records management requirements. the records should be handled in accordance with paragraphs (2) and (3) below.

(2) If this contract does not have records management requirements, except as provided in paragraph (3) of this section, upon termination of this Contract, for any reason, the contractor shall return or destroy all Protected Health Information received from the government, or created or received by the contractor on behalf of the government. Thls provision shall apply to Protected Health Information that is in the possession of subcontractor or agents of the contractor. The contractor shall retain no copies of the Protected Health Information.

(3) If thls contract does not have records management provisions and the contractor determines that returning or destroying the Protected Health Information is infeasible, the contractor shall provide to the government notification of the conditions that make return or destruction infeasible. Upon mutual agreement of the government and the contractor that return or destruction of Protected Health Information is infeasible, the contractor shall extend the protections of this contract to such Protected Health Information and limit further uses and disclosures of such Protected Health Information to those purposes that make the return or destruction infeasible, for so Jong as the contractor maintains such Protected Health Information.

)9

Miscellaneous

(a) Regulatory References. A reference in this Clause to a section in DOD 6025.lSR, Privacy Rule or Security Rule means the section as in effect or as amended, and for which compliance is required.

(b) Survival. The respective rights and obligations of Business Associate under the "Effect of Termination" provision of this Clause shall survive the termination of this Contract.

(c) Interpretation. Any ambiguity in this Clause shall be resolved in favor of a meaning that permits the government to comply with DOD 6025.lSR, the CFR Privacy Rule. the CFR Security Rule and AFI 41-217.

APPENDIXS

EQUIPMENT INFORMATION

Mfr. Serial No.

Nomenclature Manufacturer Common Model

Nameplate Model

IN02750 ANALYZER, LABORATORY,

BREATH, CARBON

DIOXIDE

VIASBNSOR GIOO GIOO

BCN020688 BATTERY, EXTERNAL

DEFIBRILLATOR

PBYSIO-

CONTROL

CORP

LI-ION 3206735-000

12490469 CALIBRATOR,

MECHANICAL PRESSURE

SENSOR

INFICON PILOT

PLUS

PILOT PLUS

3CC04603YG COMPUTER, BANDBBLD RTI

ELECTRONICS

INC

BARRACUDA IPAQ 111

1181 DUAL TEST LUNG MICHIGAN

INSTRUMENTS

INC

DUAL

ADULT TTL

171466 EXTERNAL POWER METER OPHIR

OPTRONICS

INC

ORION

LASER CAL

ORION TH

3261020 FLOWMETBR, GAS,

IHSPECTION/MAINTENANC

E

PLtJKE

BIOMEDICAL

VT PLUS

VT PLUS HF

2387318-

FLOWMETER, GAS,

INSPBCTION/MAINTBNANC

E

FLtJKE

BIOMEDICAL

ACCU LUNG ACCU LUNG

4088123701

FLOWMETER, GAS,

RESPIRATORY,

ANESTHETIC/MEDICAL

GAS

TSI CERTIFIER

FA+

4088D

650 FREQUENCY COUNTER ENGINEERED

SYSTEM

XR201/MS 8206

XR201-2804 FREQUENCY COUNTER ENGINEERED

SYSTEMS &

DESIGNS INC

XR201/MS XR201/MS

8291066 METER, AMPERE FLUKE

BIOMEDICAL

Y8100 DC/AC PROBE

7- 6133/1233

METER, AMPERE EXTECB

INSTRUMENTS

CORP

MULTIMETE

R

E05043

62614454 METER, AMPERE FLUKE

BIOMEDICAL

Y8100 AC CURRENT

PROBE

103913 METER, AMPERE NUCLEAR

ASSOC

07-487 07-487

5451 METER, LIGHT OLYMPIC

MEDICAL

BILIMETER MODEL 22

DM3-

10114536

METER, MILLIAMPERE-

SECOND (MAS)

RTI

ELECTRONICS

INC

BARRACUDA MAS-3B

109371 METER, MILLIAMPERE-

SECOND (MAS)

FLUKE

BIOMEDICAL

MA/MAS

METER

35035

2831050 METER, PRESSURE FLUKE

BIOMEDICAL

DPM4 DPM4-1G

8784015 METER, PRESSURE FLUKE

BIOMEDICAL

DPM3 DPM3

MANOMETER

2814069 METER, PRESSURE FLUKE

BIOMEDICAL

DPM4 DPM4-1G

1834014 METER, PRESSURE FLUKE

BIOMEDICAL

DPM4-1G DPM4-1G

1834013 METER, PRESSURE FLUKE

BIOMEDICAL

DPM4-1G DPM4-1G

2815004 METER, PRESSURE FLUKE

BIOMEDICAL

DPM4 DPM4-1G

8784014 METER, PRESSURE FLUKE

BIOMEDICAL .

DPM3 UNIV

BIOMETER

25772 METER, VIBRATION BIOTEK INC UW-11 UW-II/UWIII

805117- 001550

METER, X-RAY KVP,

NONINVASIVE

GAMMEX RMI

INC

330 DIAVOLT

MPD•

10110083

METER, X-RAY KVP,

NONINVASIVE

RTI

ELECTRONICS

INC

BARRACUDA BARRACUDA

MPD

805117- 001560

METER, X-RAY KVP,

NONINVASIVE

GAMMEX RMI

INC

330 DIAVOLT

TL48699020 MONITOR/CONTROLLER,

OXYGEN

FLUKE

BIOMEDICAL

MAX 02 + R217P72

32262903 OSCILLOSCOPE FLUKE

BIOMEDICAL

190M4

SCOPEMETE

R

190M-4

B020530 OSCILLOSCOPE TEKTRONIX

INC

DPO 2012B DPO 2012B

1856560 PBOTOTACHOMETER MONARCH

INSTRUMENT

POCKET

LASER

PLT200

832516 PHOTOTACBOMETBR BLECTROMATI

C EQUIPMENT

co

CHECK

LINE

CDT-lOOOHD

90151003 POWER METER,

ULTRASOUND,

THERAPEUTIC UNIT

OHMIC

INSTRUMENTS

co

UPM UPM-DT-

lOOOPA

BCl- 10110141

RADIOGRAPHIC QUALITY

ASSURANCE DEVICE

RTI

ELECTRONICS

INC

BARRACUDA BARRACUDA

348 RADIOGRAPHIC QUALITY

CONTROL DEVICE

FLUKE

BIOMEDICAL

KVP

DIVIDER

35080M

730 RADIOGRAPHIC QUALITY

CONTROL DEVICE

FLUKE

BIOMEDICAL

TRIAD TNT 35050AT

108027 RADIOMETER,

ULTRAVIOLET

DEMETRON

RESEARCH

100 100

6050992 SAMPLER,

ENVIRONMENTAL, AIR

FLUKE

BIOMEDICAL

INCU

INCUBATOR

INCU

INCUBATOR

32350132 SCALE, CLINICAL,

PRECISION

SARTORIUS

CORP

PRACTUM

2102-lS

PRACTUM

2102-lS

24154757 SCALE, CLINICAL,

PRECISION

ACCULAB PRACTUM VIC-212

50099 SIMULATOR, CARDIAC FLUKE

BIOMEDICAL

PS320

FETAL SIM

2583030

207398 SIMULATOR, CARDIAC,

ELECTROCARDIOGRAPHY

FLUKE

BIOMEDICAL

MPS450 MULTIPARAMT

R SIM

1824031 SIMULATOR,

MULTIPARAMETBR

l'LUKE

BIOMEDICAL

PROSIM8 PR0SIM8

1824035 SIMULATOR,

MULTIPARAMETER

FLUKE

BIOMEDICAL

PR0SIM8 PR0SIM8

C0112 SIMULATOR,

RESPIRATION, LUNG

INGMAR

MEDICAL

QUICKLUNG 15 00 101

7730 SIMULATOR,

TEMPERATURE

MEDIVANCE 741-00 741-00

7068065 SIMULATOR,

TEMPERATURE

WELCH ALLYN

INC

9600 PLUS 9600 PLUS

CALIBR

13362422 SIMULATOR,

TEMPERATURE

WELCH ALLYN

INC

9600 PLUS 01802-110

1839063 SIMULATOR, TRANSDUCER

OUTPUT, PULSE

OXIMETRY

FLUKE

BIOMEDICAL

PROSIM

SPOT

Nl0140

1839062 SIMULATOR, TRANSDUCER

OUTPUT, PULSE

OXIMETRY

FLUKE

BIOMEDICAL

PROSIM

SPOT

PROSIM SPOT

2193898 STROBE LIGHT

TACHOMETER

MONARCH

INSTRUMENT

NOVA-

STROBEDB

NOVA-

STROBEDB

C7EC02192 TESTER, BATTERY CADEX

ELECTRONICS

INC

C-SERIES C7400ER-C

1854058 TESTER, DEFIBRILLATOR FLUKE

BIOMEDICAL

IMPULSE

7000DP

7000DP

1854055 TESTER, DEFIBRILLATOR FLUKE

BIOMEDICAL

IMPULSE

7000DP

7000DP

L2027 TESTER, ELECTRICAL

SAFETY

DALE

TECHNOLOGY

INC

LT544D

PLUS

LT544D

L2029 TESTER, ELECTRICAL

SAFETY

DALE

TECHNOLOGY

INC

LT544D

PLUS

LT544D

L2028 TESTER, ELECTRICAL

SAFETY

DALE

TECHNOLOGY

INC

LT544D

PLUS

LT544D

28315 TESTER, ELECTRICAL

SAFETY

FLUKE

BIOMEDICAL

5000C MEDTESTER

8979008 TESTER, ELECTRICAL

SAFETY

DALE

TECHNOLOGY

INC

LT544D

PLUS

LT544D PLUS

9340024 TESTER, ELECTRICAL

SAFETY

DALE

TECHNOLOGY

INC

LT544D

PLUS

LT544D

L2025 TESTER, ELECTRICAL

SAFETY

DALE

TECHNOLOGY

INC

LT544D

PLUS

LT544D

9340022 TESTER, ELECTRICAL

SAFETY

DALE

TECHNOLOGY

INC

LT544D

PLUS

LT544D

1099049 TESTER, ELECTRICAL

SAFETY

FLUKE

BIOMEDICAL

SAFETY

ANALYZER

ESA612

1120017 TESTER, ELECTRICAL FLUKE SAFETY ESA612

SAFETY BIOMEDICAL ANALYZER

3234037 TESTER, ELECTRICAL FLUKE ESA620 ESA620

SAFETY/MEDICAL DEVICE BIOMEDICAL

PERFORMANCE

3246752 TESTER, ELECTRICAL FLUKE ESA620 ESA620

SAFETY/MEDICAL DEVICE BIOMEDICAL

PERFORMANCE

200333 TESTER, FLUKE QA-ESII QA-ESII

ELECTROSURGICAL UNIT BIOMEDICAL

200373 TESTER, FLUKE QA-ESII QA-ES

ELECTROSURGICAL UNIT BIOMEDICAL

6305 TESTER, ENDOSCOPE, DALE RIGID 301

AIR LEAK TECHNOLOGIE SCOPE

S INC TEST

3247023 TESTER, EXTERNAL FLUKE SIGMAPACE SIGMAPACE

CARDIAC PACEMAKER BIOMEDICAL 1000 1000

Bl30328- TESTER, LASER BEAM GE MEDICAL 00- 00-878150-

3896 SYSTEMS 878150-07 07

9834004 TESTER, LEAKAGE FLUKE ULT800 ULT800

CURRENT BIOMEDICAL

BF100154 TESTER, MEDICAL GAS FLUKE VT305 VT305

SYSTEM OUTLET BIOMEDICAL

4081125000 TESTER, PNEUMATIC TSI INC CERTIFIER 4081G

8 FA+

Cl- TESTER, RESISTANCE, IET LABS RESISTANC RS-200

07161503 LINE CORD INC E SOBST

Sl0000273 THERMOMETER, SMITHS LEVELl HLTA-40

ELECTRONIC MEDICAL TEMP CBEK

Sl0000278 THERMOMETER, SMITHS LVL 1 DSTA-40

ELECTRONIC MEDICAL TEMP

ECN015721 THERMOMETER, ELECTRONIC

ASD, INC CHECK

EXERGEN CAL KIT TAT-2000

90950847 THERMOMETER,

ELECTRONIC

CORP

FLUKE

BIOMEDICAL

971 971

105841 TRIAD X-RAY KIT FLUKE VICTOREBN 8000

BIOMEDICAL NERO

SJN9 WEIGHT SET, RICE LAKE WEIGHT CLASS F

CALIBRATION WEIGHING SET

SYSTEMS

Equipment specifics: Equipment is subject to be changed out or replaced. Must allow flexibility for changing of like items or adding new items.