ATT 2 - FA302220Q0318 Performance Work Statement Dated 17 July 2020.pdf

PERFORMANCE WORK AND SERVICE MAINTENANCE STATEMENT (PWS)

For

COSTS PER TEST INCLUDING ONE (1)

WATERLESS CLINICAL CHEMISTRY ANALYZER

14TH MEDICAL GROUP, COLUMBUS AFB, MISSISSIPPI

(NON-PERSONAL SERVICE)

17 JULY 2020

Attachment 2 - FA302220Q0318 Performance Work Statement Date 24 August 2020

TABLE OF CONTENTS

Section Title Page(s)

1 Description of Services/General Information/General Definitions 3-10

2 Services Summary (SS) 11-12

3 Government Furnished Property, Equipment, Supplies, Services 13

Appendix A Test Menu w/ Estimated Annual Usage 15

Appendix B Health Insurance Portability and Accountability Act (HIPAA) of 1996 17-20

PERFORMANCE WORK STATEMENT

For

COSTS PER TEST INCLUDING ONE (1) WATERLESS

(DRY SLIDE) CLINICAL CHEMISTRY ANALYZER

SECTION 1

DESCRIPTION OF SERVICES, GENERAL INFORMATION, GENERAL

DEFINITIONS

1.0. SCOPE OF WORK: The contractor shall provide one (1) waterless Cost per Test Clinical Chemistry Dry Slide Analyzer of the latest technology available (no refurbished or remanufactured equipment allowed) including test equipment and associated software, computers, power ware necessary for operation and supply all initial analyzer validation supplies and testing reagents in accordance with the terms in this Performance Work Statement. The contractor shall provide all support needed to include equipment repairs, labor, travel, and materials not government furnished, necessary to keep unit operational to manufacturer’s specifications seven (7) days per week. The contractor shall provide new user manuals, or updates on user manuals, when changes are made. The contractor shall provide scheduled recurring/preventive maintenance inspections (PMIs); calibrations; on-site emergency services;

and ensure equipment complies with all regulatory requirements. The analyzer shall meet the performance characteristics for accuracy and precision as defined by the College of American Pathologists (CAP), 1988 Clinical Laboratory Improvement Act (CLIA’88) and the Clinical and Laboratory Standards Institute (CLSI). The contractor must assess equipment, workflow, volumes, and space to meet the individual site requirements with minimum cost. The contractor must propose the suggested/recommended equipment/reagents that will meet the requirements of the facility. The contractor shall provide above services at the 14th Medical Group, Clinical Laboratory Flight, Columbus AFB, MS, also referred to as the Military Treatment Facility (MTF) herein. The performance shall be in accordance with (IAW) the requirements contained in this Performance Work Statement (PWS) and accreditation standards of the College of American Pathologists (CAP), Joint Commission (JC), the Health Services Inspections (HSI) as well as the current USAF Referral Management Guidelines. All references within this document stated as singular analyzer, or system within this PWS applies to, includes requirements for, or covers the waterless clinical chemistry analyzer required by this PWS/contract.

1.1. DESCRIPTION OF SERVICES:

1.1.1. Installation: Placement and installation of the waterless (dry slide) clinical chemistry analyzer and all equipment components inclusive, including, but not limited to, all laboratory associated mechanical, electromechanical parts and supplies. Installation shall conform to Industry Standards and shall meet or exceed all applicable codes to include Local/State Regulations, National Fire Protection Association (NFPA), building codes, communication codes, and other codes for each utility identified.

1.1.1.1. The contractor shall provide a Project Manager to oversee system installation and trained technician to perform correlations and validations studies. The contractor shall provide all validation reagents and materials needed to perform these tasks. The contractor shall have electrician and engineering specialists on site when the waterless (dry slide) clinical chemistry analyzer is delivered for proper equipment installation.

1.1.1.2. The contractor shall provide an Uninterrupted Power Supply (UPS) required for emergency use which must be installed in the appropriate location as determined by the MTF.

This UPS is a self-operated unit that provides enough power, during a commercial power outage, to ensure the waterless (dry slide) clinical chemistry analyzer system remains operational.

1.1.1.3. The contractor shall complete cleanup (upon installation) of the work area and disposal of debris, to include any need for cosmetic repairs on walls, floorings, ceiling, etc.

1.1.1.4. The contractor is responsible for the removal of the analyzer at the end of the contract period or at the government’s discretion.

1.1.2. Analyzer Requirements:

1.1.2.1. Technical Specifications: Equipment must be able to process 5 mL, 7 mL, 10 mL collection tubes; and 0.5 mL and 2.0 mL sample cups to meet Laboratory workload requirements. Dimensions will not exceed 59 in W x 35 in D x 53 in H due to space restrictions in the facility.

1.1.2.2. The contractor shall provide a waterless (dry slide) analyzer that meets the requirements stated in Appendix A, the performance characteristics for accuracy and precision as well as be compatible with the Hospital Information System (HIS)/Laboratory Information System (LIS). The analyzers, reagents, and materials shall meet the following criteria:

1.1.2.2.1. Analyzer must have waste contained within the system and not require plumbing, drains, or water purification/filtration system.

1.1.2.2.2. To prevent cross contamination, the analyzer must use disposable tips for patient and reagent sampling and must not require carryover studies to be performed.

1.1.2.2.3. Daily Maintenance must not exceed 15 minutes, weekly maintenance must not exceed 30 minutes, and monthly maintenance must not exceed 45 minutes.

1.1.2.2.4. Analyzer and assays shall be FDA approved (the contractor must provide proof of certification). The assay, instrumentation or the company (contractor) cannot have FDA warning letters issued over the past 24 months.

1.1.2.2.5. Analyzer must provide critical process monitoring and management of system maintenance and quality control (QC) by verifying, documenting, and resolving diagnostic checks throughout sample processing.

1.1.2.2.6. Be able to perform quality control on chemistries and immunoassays no more than once per 24 hours, unless required due to calibration, correlation, maintenance, etc

1.1.2.2.7. Analyzer shall have the capability to perform Direct ISEs (Na, K, and Cl).

1.1.2.2.8. Analyzer must provide simple operation with continuous loading and unloading of samples and reagents without stopping the analyzer during testing to eliminate bottlenecks during peak testing periods. Analyzer must be able to prioritize STAT specimens.

1.1.2.2.9. Analyzer must provide specimen integrity by evaluating the amount of hemolysis, icterus, and turbidity with no effect on throughput and without using additional patient sample, reagents, and/or consumables. It must flag only the assays affected by the interferent for both chemistry and immunoassay testing and send flags and level to the LIS or data management system.

1.1.2.2.10. Provide sample management with clot detection, bubble detection, liquid Level- Sensing short-sample detection. The system must save the sample if a clot or bubble is detected during primary aspiration.

1.1.2.2.11. Analyzer must have on-board dilution. Specifically, auto dilution, auto repeat, and auto reflex capability. Be self-monitoring and alert operators to prompt action, avoiding testing delays.

1.1.2.2.12. Analyzer shall have a calibration stability of at least six months for routine chemistry testing and 28 days for immunoassay testing.

1.1.2.2.13. Analyzer shall provide ability to store, print, and retrieve calibration curves and be capable of storing calibration curves for at least two different lot numbers of reagents held on-board.

1.1.2.2.14. Require minimal reagent preparation, mixing, and/or reconstitution.

1.1.2.2.15. The system must use a digital bar code technology, one that supports multiple barcode formats e.g., Code 39 or Code 128, to read labeled sample tubes and positive tube identification.

1.1.2.2.16. Have turnaround time for a single result of less than 20 minutes for chemistry assays.

1.1.2.2.17. Support multiple lots onboard and automatically switch lots when one is depleted.

Offers extended calibration stability with the same lot.

1.1.2.3. The contractor shall provide consumable pricing inclusive for all tests listed in Appendix A. Consumables include but are not limited to supplies, reagents, diluents, consumable/disposable items, QC materials, parts, accessories, and any other item required for the proper operation of the contractor’s equipment.

1.1.2.4. The contractor shall provide all reagent, materials, supplies, and resources for 100% of tests listed in Appendix A.

1.1.3. Service/Recurring/Preventive/Corrective Maintenance (PM’s): The contractor shall provide an on-site Field Service Agent to perform all required preventive maintenance Inspections (PMI), calibrations, and emergency services required by the manufacturer and other regulatory agencies.

1.1.3.1. Scheduled preventative maintenance calls shall occur at a frequency to meet minimum manufacture’s requirements to meet regulatory agencies standards and to keep the analyzers in optimal operating condition. The contractor shall coordinate service calls with the MTF Biomedical Maintenance (BMET).

1.1.3.2. A service summary shall be provided to the BMET department and laboratory department, detailing each on-site service incident and repairs made by the Field Service Agent.

It shall provide written documentation of each PMI visit as to items performed during the PMI and any parts that were replaced.

1.1.3.3. The contractor shall provide a company service technician for support services which must be performed on-site. The quality of the waterless clinical chemistry equipment shall meet or exceed reasonable standards of commercial practice that is determined by the same authority that governs military clinical laboratory service professionals in the same discipline.

1.1.3.4. Emergency Service Calls. Response time to emergency service requests shall not exceed 24 hours, excluding weekends and holidays. On-site emergency service is the repair necessary to return the system to its intended functional state of operation. The contractor shall provide on-site repair to correct all malfunctions that occur. The service technician shall continue uninterrupted service until the system is operational according to manufacturer’s specifications.

Providing travel and overtime, all tools, test equipment, parts, and supplies required to perform emergency services calls shall be the responsibility of the contractor.

1.1.3.4.1. The equipment shall be repaired within 24 continuous clock hours after arrival to the equipment site, excluding holidays. Repair actions continuous until repair is complete unless parts are unavailable. The need for unavailable parts will suspend the time limit until parts are obtained. These parts shall be available within 24 – 48 hrs.

1.1.3.4.2. Consults with equipment operators regarding equipment performance.

1.1.3.4.3. Performs operational checks on all systems to include, but not limited to, QC after PM and repairs, correct noted deficiencies, and meet all regulatory requirements.

1.1.3.4.4. Replaces worn or defective parts (those parts that may fail before the next PMI).

1.1.3.5. Equipment Updates. The contractor shall furnish and install all software updates and equipment modifications provided by the manufacturer. These updates are provided at no additional cost to the government and installed no later than the next PMI or visit.

1.1.3.6. Equipment malfunctions. During regular and after duty hours, all equipment malfunctions will immediately be reported to the contractor via telephone.

1.1.4. Technical/General Services: Contactor shall provide Quality Customer Service:

1.1.4.1. Technical Phone Support services and Emergency service calls Monday through Friday coverage from 8:00 A.M. - 5:00 P.M.

1.1.4.2. The contractor shall provide on-site service coverage Monday through Friday from 8:00 A.M. – 5:00 P.M.

1.1.4.3. The contractor shall not be required to deliver on any federal holiday, but may be required to deliver on family days or base down days.

1.1.4.4. Technical Specialist Support, including method validation and on-site training.

1.1.5. Training: Contractor shall provide training on analyzer operations, such as loading samples and reagents, ordering and running tests and QC, interpreting, printing, and sending test results to the LIS, basic preventative maintenance, and basic troubleshooting for government personnel.

1.1.5.1. Contractor will provide training for government personnel (minimum 2 slots implementation year).

1.1.5.2. Contractor will provide one training slot per year for duration of the contract.

1.1.5.3. Contractor will provide training for government laboratory staff when updates or system changes have been made to the analyzer.

1.2. GENERAL INFORMATION:

1.2.1. Contract Manager:

1.2.1.1. The contractor shall provide a contract manager and an alternate that shall be responsible for the performance of the work. These individuals shall have full authority to act for the contractor on all contract matters relating to the daily operation of this contract and shall be designated, in writing, to the Contracting Officer (CO) before the contract start date. The alternate contract manager shall act for the contract manager when the manager is absent. The contractor shall notify the CO when the alternate has primary responsibility.

1.2.1.2. The contract manager or alternate shall be available within 24 hours to meet on the installation or by telecom with government personnel designated by the CO during normal duty hours.

1.2.2. Hours of Operation: On delivery days, supplies and reagents shall be delivered to the 14th Medical Group weekdays between the hours of 8:00 A.M. – 4:30 P.M.

1.2.3. Performance of Services During Crisis Declared by the National Command Authority or Overseas Combatant Commander: On occasion, services may be required to support an activation or exercise of contingency plans outside the normal duty hours.

Emergency situations (i.e., accident and rescue operations, civil disturbances, natural disasters, military contingency operations, and exercises) may necessitate the contractor to provide increased or reduced support as determined by the CO. The government will negotiate an equitable adjustment with the contractor for the cost of these emergency requirements.

Otherwise, under circumstances when the base is closed due to severe weather, these services will be considered non-essential.

1.2.4. English Language Requirement: All contractor personnel shall read, understand, speak, and write English fluently.

1.2.5. Appearance: Contractor personnel shall present a professional, conservative, and neat appearance. Contractor personnel shall display an identification badge on their person at all times when in 14th MDG facilities.

1.2.6. Contractor Requirements/Qualification/Experience/Training:

1.2.6.1. Requirements: The Laboratory Technical Specialist shall oversee the completion of this work, representing the contractor and shall supervise and train 14th Medical Group laboratory personnel to ensure compliance with all provisions of this contract.

1.2.6.2. Qualification: Prior to assigning an individual to the position of Laboratory Technical Specialist, the contractor shall have a national Medical Technologist (MT)/ Clinical Laboratory Scientist Certification and have completed the training per contractor requirements.

1.2.6.2.1. Experience/Training: The Project Manager shall have at least three (3) consecutive years of prior experience in the health care industry within the last five (5) years.

1.2.7. Personnel Training:

1.2.7.1. The contractor shall conduct and document formal training of all government personnel to ensure competent performance. Training covered shall ensure compliance with the provisions of this contract. The contractor shall provide a training plan on how and what subjects all personnel are to be trained.

1.2.7.2. The contractor shall submit the training plan to the CO for review and approval. An updated copy of the training plan shall be provided to the Contracting Officer’s Representative (COR) as changes occur.

1.2.8. Reporting Requirements: The contractor shall comply with the requirements of Volume 1, Air Force Instruction (AFI) 71-101, Criminal Investigations, and paragraph 1.1 of Volume 2, Protective Service Matters. Contractor personnel shall report to an appropriate authority any information or circumstances of which they are aware that may pose a threat to the security of

DoD personnel, contractor personnel, resources, classified or unclassified defense information and government security information.

1.2.9. Security/Pass and Identification Items: The contractor shall ensure the pass and identification items required for contract performance are obtained for personnel and non-government owned vehicles. All vehicles that enter military installations shall be properly registered, licensed, insured and safety inspected for compliance with state and local laws.

Contractor shall be responsible for the return of all pass and identification items at expiration or termination of contract. Final payment can be withheld if identification items are not returned.

1.2.10. Base Passes:

1.2.10.1. Contractor personnel shall obtain base passes for entry onto Columbus AFB in compliance with AFI 10-245, Antiterrorism (AT), 21 September 2012.

1.2.10.2. A minimum of 15 days’ notice is required to obtain base passes. The contractor must submit the following pertinent information to the 14th laboratory POC no later than 15 days before expected work date or pass expiration date:

a. Full name with middle initial

b. Date of birth

c. Social security number

d. Gender

e. Complete address

f. Sponsoring agency

g. Sponsor’s name and rank

h. Contractor’s company name

i. Contractor's phone number

j. Contract Number

k. Contract period of performance

1.2.10.3. Exclusions: Contractor personnel are not authorized entry to Columbus AFB if they have been convicted of any of the following felony offenses:

a. Murder

b. Aggravated sexual assault or rape

c. Child molestation

d. Espionage

e. Sedition

f. Treason

g. Violence at international airports

h. Conspiracy or attempt to commit any of the above offenses

1.2.10.4. In addition, contractor personnel are not authorized entry to Columbus AFB if they have been convicted of any of the following offenses:

a. Illegal sale, distribution, or manufacture of explosives or weapons

b. Arson

c. Importation or manufacture of a controlled substance

d. Extortion

e. Bribery

f. Kidnapping or hostage taking

g. Sexual assault

h. Armed robbery I. Illegal possession or use of an explosive or weapon

j. Distribution or intent to distribute a controlled substance

k. Conspiracy or attempt to commit any of the above offenses

l. Two or more felony convictions of any type

1.2.11. Accident Reporting: The contractor shall report all occupational exposures and all accidents while on duty at the 14th MDG hospital compound resulting in death, trauma, or occupational disease to the COR . All accidents shall be reported within 24 hours of their occurrence. The COR or designated representative may require the contractor to complete certain forms to document exposures and/or accidents. The contractor shall complete these forms promptly at no additional cost to the government.

1.2.12. Traffic Laws: The contractor shall comply with the installation traffic code as specified in Mississippi State Law and AFI 31-218, Motor Vehicle Traffic Supervision, and may be subject to search prior to authorization to proceed through gate.

1.2.13. Weapons, Firearms, and Ammunition: Contractor personnel are prohibited from possessing weapons, firearms, or ammunition, on themselves or within their contractor or privately owned vehicle while on Columbus AFB.

1.2.14. Smoking in Facilities: Contractors are advised that Commanders have placed restrictions on the smoking of tobacco products in Air Force 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. Contractor personnel and visitors are subject to the same restrictions as government personnel. Smoking is permitted only in designated smoking areas. 14th MDG is totally smoke free.

1.2.15. Contractor Furnished Items and Services: Except for those items or services specifically stated in Section 3 to be government-furnished, the contractor shall furnish all materials and labor required to perform this contract in accordance with all of its terms and conditions. It is the contractor’s responsibility to ensure their contractor personnel are familiar with and understand the contents of this PWS as well as the company’s handbooks/handouts, etc.

prior to beginning work at this MTF.

1.2.16. Physical Security: The contractor shall be responsible for safeguarding all government property provided for contractor use. At the end of each work period, all government equipment and materials will be secured.

1.2.17. Inventory: Within ten (10) days of contract start, the contractor and the government shall conduct an inventory of all items used on Columbus AFB, MS. A semi-annual inventory will be conducted on the analyzer between the 14th MDG laboratory POC and the contractor.

1.3. GENERAL DEFINITIONS: The following terms shall have the meaning set forth in accordance with the terms of this PWS.

1.3.1. Commander. MTF Commander, Flight Commander or a designated representative of the activity designated in this contract.

1.3.2. 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.

1.3.3. Contractor. The offeror identified in block 15A of Standard Form 33. The contractor is an independent contractor and responsible for its own liability.

1.3.4. Medical Treatment Facility (MTF). Air Force hospitals or clinics, including all activities providing outpatient and/or in-patient healthcare services for authorized personnel.

1.3.5. Quality Assurance Program (QAP). A systematic program designed to provide insight into the service provider’s performance. The program focuses on existing data/systems to obtain process improvement and enhance performance.

1.3.6. Quality Control (QC). Those actions taken by a contractor and the government to control the quality of output and to ensure that they conform to contract requirements and reasonable standards of medical care.

1.3.7. Services Summary (SS). Prescribes how the government plans to (1) assess contractor performance and, (2) describes an acceptable level of performance (threshold) for each task.

SECTION 2

SERVICES SUMMARY

2.0. SERVICES SUMMARY (SS): The contract service requirements are summarized in performance objectives that relate directly to mission essential items. The performance threshold briefly describes the minimally 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) clause 52.212-4 (a), Contract Terms and Conditions - Commercial Items, Inspection/Acceptance, will be used to remedy all deficiencies. The absence of any contract 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/Services Summary Item #

PWS

Para

Performance Threshold Surveillance

SITE PREPARATION AND INSTALLATION

SS#1 - Placement and installation of one Waterless Clinical Chemistry Analyzer and all equipment components inclusive, but not limited to, all laboratory associated mechanical, electromechanical parts and supplies. Installation shall conform to Industry Standards and shall meet or exceed all applicable codes to include Local/State Regulations, NFPA, and building codes for each utility identified.

1.1.1. 100% Initial (100%) Surveillance

SS#2 – The contractor shall have electrician and engineering specialists on site when the Waterless Clinical Chemistry Analyzer is delivered for proper equipment installation.

1.1.1.1.

100% Initial (100%)

SS#3 - Provides the required UPS 1.1.1.2. 100% Periodic Surveillance

SS#4 – Complete clean-up of the work area during installation

1.1.1.3. 100% Periodic

SERVICE/ PREVENTIVE/ CORRECTIVE MAINTENANCE

SS#5 - Provides service, Preventive Maintenance assistance, Technical Phone support, and Emergency service calls Monday through Friday coverage from 8:00 A.M. - 5:00 P.M.

1.1.3.

1.1.4.

100% Periodic Surveillance

Customer Complaint

SS#6 – Furnish and install all software updates and equipment modifications provided by the manufacturer at no additional cost.

1.1.3.5. 100% Periodic Surveillance

SS#7 – Provides analyzer that must meet the requirements stated and performance characteristics defined by CLIA’88 & CLSI

1.0. 100% Periodic Surveillance

SS#8 – Provides analyzer and assays that are FDA approved and have no FDA warning letters issued over the past 24 months.

1.1.2.2.4. 100% Periodic Surveillance

SS# 9 – Provides a Project Manager to oversee system installation and technician /Laboratory Technical Specialist to perform correlation, validation and provides all validation reagent/materials needed to perform these tasks.

1.1.1.1.

1.2.6.1.

100% Periodic Surveillance

SS# 10 – The contractor shall provide all reagent, materials, supplies, and resources for 100% of tests listed in Appendix A.

1.1.2.4. 100% Periodic Surveillance

SS# 11 - Contractor shall provide Quality Customer Service: Technical Phone Support services and Emergency service calls Monday through Friday coverage from 8:00 A.M. - 5:00 P.M.

1.1.4. - 1.1.4.4.

100% Periodic Surveillance

Customer Complaint

SS# 12 - Provide training for government personnel as required by the PWS.

1.1.4.4.

1.1.5.- 1.1.5.3

1.2.7. - 1.2.7.2.

100% Periodic Surveillance

Customer Complaint

SS# 13 - The contractor shall perform all required preventative maintenance. The use of the Waterless Clinical Chemistry Analyzer shall cover the range of services provided in a civilian medical treatment facility with all associated maintenance.

1.1.3. 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 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 his determination if further action is necessary.

2.1.1. The government reserves the right to inspect throughout all phases of site preparation and construction prior to delivery and installation of the Waterless Clinical Chemistry Analyzer, post installation and for functionality prior to patient encounters. The government may inspect each task as completed or increase the number of quality assurance inspections if deemed appropriate because of repeated failures.

2.1.2. The government will periodically evaluate the contractor’s performance during post Waterless Clinical Chemistry Analyzer installation and 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. The government COR, after reviewing customer comment cards, will take necessary action if a complaint falls within the SS.

2.1.3. 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.

2.1.3.1. When the defects in services cannot be corrected by re-performance, the government may by contract or otherwise, perform the services and charge to the contractor any cost incurred by the government that it is directly related to the performance of such service, or

2.1.3.2. When the defects in services cannot be corrected by re-performance, the government may terminate the contract for default.

2.2. QUALITY CONTROL (QC): The contractor shall develop and maintain a complete quality control program for the performance requirement of this contract. The contractor shall develop and implement procedures to identify, prevent, and ensure non-performance and continual repeat of defective service does not occur. A written Quality Control Plan (QCP) shall be submitted by the contractor to the CO for review and feedback NLT 30 days after the leasing award or at the post award conference (whichever is earlier). The plan shall specifically address the contractor’s strategy to provide quality workmanship, continual process improvement, preventing deficiencies, and for correcting deficiencies as required. The contractor shall ensure that the following issues are addressed in their QCP:

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

2.2.2. A description of how the records shall be kept. Records must document all inspections and corrective or preventive actions taken.

2.3. QUALITY ASSURANCE (QA): The government shall inspect and evaluate the contractor’s performance to ensure services are received IAW requirements set forth in this contract. The COR shall inspect by watching actual task performance, physically checking an attribute of the completed task, checking a management information report, investigating customer complaints, 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 (1) 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, PAR or a Contract Discrepancy Report (CDR) for issuance to the contractor.

2.3.1. Failing to meet the performance threshold as outlined in the SS of these performance objectives during a contract period shall constitute an immediate progress meeting with the Multi-functional Team.

2.3.2. Failing to meet the performance threshold as outlined in the SS for any of these performance objectives in any combination for any two (2), or more consecutive or non-consecutive months in any period, could result in a warning or letter of concern from the CO.

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

2.4. SURVEILLANCE METHODS:

2.4.1. Periodic Surveillances. This method requires the COR 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 COR.

2.4.2. Customer Complaint. This method requires the customer to fill out a Customer Complaint Record (CCR) or a locally generated form provided by the COR or CO. The COR will verify the complaint and notify the contractor of valid complaints. The contractor shall acknowledge the complaint within two (2) hours and inform the COR of its recommendation.

Any deficiency will be documented and the contractor shall re-perform service immediately, if appropriate, or within 24 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 Officer 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. 100% Percent Inspection. This method requires the COR to inspect the service each time it occurs. Results will be annotated on the inspection Quality Assurance Surveillance Checklist (QASC). The inspection will be on items identified in the Services Summary as 100% Inspection as the Method of Surveillance. Any deficiency will 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.

2.5. PERFORMANCE EVALUATION MEETINGS:

2.5.1. The CO, Functional Commander, COR, other government personnel as appropriate, and the contractor shall periodically meet to discuss the contractor’s performance. 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. The minutes of these meetings will be reduced to writing, signed by the CO and any other signatures as deemed appropriate, and distributed to the functional area and the contractor.

Should the contractor not concur with the minutes, such non-concurrence shall be provided in writing to the CO within ten (10) calendar days of receipt of the minutes.

2.6. GOVERNMENT RECEIPT AND ACCEPTANCE OF GOODS:

2.6.1. Wide Area Work Flow. The COR will certify receipt of contractor services via the Wide Area Work Flow (WAWF) website. Certification of services will be accomplished using the contractor’s stand-alone invoice following the completion of the contract payment period.

2.7. GOVERNMENT FURNISHED PROPERTY, EQUIPMENT, SUPPLIES AND

SERVICES:

2.7.1. The government will provide the following equipment, supplies, and services listed below:

2.7.2. Maintain room temperature and refrigeration of supplies to optimize accurate laboratory testing.

2.7.3. The Contracting Officer’s Representative (COR) will provide the contractor the information needed to maintain adequate refrigeration for supplies and reagents, and sufficient spacing to meet the needs of the MTF upon the contract start date.

2.7.4. The government will have adequate facilities and equipment for the safe and effective operation of such service.

2.7.5. Special procedures will be established for the handling and processing of biohazard materials.

2.7.6. The government will furnish contractor personnel with appropriate Personal Protective Equipment (PPE). The government will be responsible for any repair, cleaning and inventory required for the PPE.

2.7.7. The government and contract personnel shall have joint use of all available equipment for performing services required by this contract. “Joint use” under this paragraph refers to any equipment/section within the laboratory that exists for joint use to include, but not limited to, other compatible inter-operable equipment, other network computers, and telephones within the laboratory. The government will provide administrative supplies as required.

2.7.8. The MTF will provide required government forms used in the performance of services.

2.7.9. Emergency Health Care. The MTF will provide emergency health care for contractor for injuries incurred while on duty in the MTF. These services will be billed to the contractor at the current full reimbursement rate.

APPENDIX A

Site Testing Volumes

NOTE: The estimated test quantities are subject to change; therefore, these estimates will be updated as required. If actual changes in workload cause more than a 15 percent change in the total estimated workload per contract year, then a negotiated modification to this contract will be accomplished.

ABBR Test Nomenclature Estimated Annual Count

ALB-TP Albumin-Total Protein 5,500

ALC Alcohol 720

TBIL-ALKP Total Bilirubin - Alkaline Phosphatase 4,200

AMYL Amylase 630

ALTV-AST Alanine Aminotransferase - Aspartate aminotransferase

4,200

UREA-CREA Blood Urea Nitrogen - Creatinine 4,800

GLU-CA Glucose - Calcium 6,600

ECO2 Carbon Dioxide 2,400

CL Chloride 2,250

ABBR Test Nomenclature Estimated Annual Count

CK Creatine Kinase 720

BUBC Direct/Indirect Bilirubin 2,160

FE Iron 990

HDL HDL Cholesterol 1,710

LIP Lipase 720

MG Magnesium 630

PHOS Phosphorus 900

K Potassium 2,250

NA Sodium 2,250

TRIG Triglycerides - Cholesterol 6,600

APPENDIX B

HEALTH INSURANCE PORTABILITY & 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 medical facilities of the military services and the DOD health plans are specifically listed as covered by HIPAA. Currently, HIPAA Privacy and Security Rules, as set forth in the Code of Federal Regulations, are in effect for all MTFs. 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 AF MTFs are contained in draft/final AFI 41- 217, which also contains additional Information Assurance requirements for all AF MTFs. Both DOD 6025.18-R and the final AFI 41-217, when published, are incorporated herein by reference. The draft AFI 41-217 will be an attachment to this contract in the interim. MTFs 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 Dodd 6025-18R, the Contractor and Health Care Workers meet the definition of Business Associates. 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 each MTF, whereby the Contractor and Health Care Workers agree to abide by all HIPAA Privacy and Security requirements regarding health information as defined in this clause, DOD 6025-18- R, as amended and draft/final AFI 41-217, incorporated by reference. Additional HIPAA requirements will be addressed when implemented.

1. Privacy of Protected Health Information-

(a) Definitions. As used in this clause generally refer to the CFR definition, unless a more specific provision exists in DOD 6025.18-R:

Individual has the same meaning as the term “individual” in 45 CFR 164.501 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 Information has the same meaning as the term “protected health information” in 45 CFR 164.501, limited to the information created or received by The Contractor from or on behalf of The Government.

Required by Law has the same meaning as the term “required by law” in 45 CFR 164.501.

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

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

(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 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.

(e) The Contractor agrees to report to the Government any use or disclosure of the Protected Health Information not provided for by this Contract.

(f) 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 apply through this Contract to the Contractor with respect to such information.

(g) 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.

(h) 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.

(i) 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.

(j) 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.

(k) 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 the other purposes, if such use or disclosure of Protected Health Information would not violate the Privacy Rule or the Department of Defense Health Information Privacy Regulation if done by the Government: Treatment, Payment or Healthcare Operations.

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 164.502(j)(1).

Obligations of the Government

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

(a) Upon request the Government shall provide the Contractor with the notice of privacy practices that the Government produces in accordance with 45 CFR 164.520, as well as any changes to such notice.

(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 disclose 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 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. This provision shall apply to Protected Health Information that is in the possession of subcontractors or agents of the Contractor. The Contractor shall retain no copies of the Protected Health Information.

(3) If this 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 long as the Contractor maintains such Protected Health Information.

Miscellaneous

(a) Regulatory References. A reference in this Clause to a section in the Privacy Rule or DOD 6025.18-R means the section 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 6025.18-R first and then the Privacy Rule as contained in the CFR.

2. Security of Protected Health Information

(a) Definitions. As used in this clause:

Electronic Protected Health Information has the same meaning as the term “electronic protected health information” in 45 CFR 160.103.

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

Security Rule means the Security Standards for the Protection of Electronic Protected health Information at 45 CFR part 160 and part 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, 164.103, and 164.304.

(b) The Contractor agrees to implement 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 on behalf of the Government.

(c) The Contractor agrees to report to the Government any security incident of which it becomes aware.

(d) The Contractor agrees to ensure that any agent, including a subcontractor, to whom it provides Electronic Protected Health Information that it creates, receives, maintains, or transmits on behalf of the Government, agrees to the same restrictions and conditions that apply through this Contract to the Contractor with respect to such information.

Miscellaneous

(a) Regulatory References. A reference in this Clause to a section in the Security Rule…