Inactive Total Small Business Set-Aside (FAR 19.5)

The contractor shall provide two (2) Integrated Coagulation Analyzers (no refurbished or remanufactured equipment allowed), test equipment and associated power ware, and all validation supplies and re... The contractor shall provide two (2) Integrated Coagulation Analyzers (no refurbished or remanufactured equipment allowed), test equipment and associated power ware, and all validation supplies and reagents. The contractor shall provide all support needed to include equipment repairs, labor, travel and materials not government furnished, necessary to keep both units 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 analyzers 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, work flow commensurate to patient volume, and meet space requirements as outlined in paragraph 1.1.1.2. 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 633d Medical Group, Pathology Flight, Joint Base Langley-Eustis (JBLE), VA, Langley Air Force Base (LAFB) division, 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 CAP, Food and Drug Administration (FDA), The Joint Commission (TJC), the Health Services Inspections (HSI) as well as the current United States Air Force (USAF) Referral Management Guidelines

Inactive

PERFORMANCE WORK STATEMENT (PWS) For INTEGRATED COAGULATION ANALYZERS 633D MEDICAL GROUP, JOINT BASE LANGLEY-EUSTIS, VIRGINIA (NON-PERSONAL SERVICE) 20 March 2020 20 March 2020 TABLE OF CONTENTS Secti... PERFORMANCE WORK STATEMENT (PWS) For INTEGRATED COAGULATION ANALYZERS 633D MEDICAL GROUP, JOINT BASE LANGLEY-EUSTIS, VIRGINIA (NON-PERSONAL SERVICE) 20 March 2020 20 March 2020 TABLE OF CONTENTS Section Title Page(s) 1 Description of Services/General Information/General Definitions 3 - 12 2 Services Summary (SS) 13 - 17 3 Government Furnished Property, Equipment, Supplies, Services 18 Appendix A Test Menu w/ Estimated Annual Usage 19 Appendix B Appendix C Health Insurance Portability and Accountability Act (HIPAA) of 1996 Contract Manpower Report 20 - 24 25 20 March 2020 PERFORMANCE WORK STATEMENT for INTEGRATED COAGULATION ANALYZERS SECTION 1 DESCRIPTION OF SERVICES, GENERAL INFORMATION, GENERAL DEFINITIONS 1.0. SCOPE OF WORK. The contractor shall provide two (2) Integrated Coagulation Analyzers (no refurbished or remanufactured equipment allowed), test equipment and associated power ware, and all validation supplies and reagents. The contractor shall provide all support needed to include equipment repairs, labor, travel and materials not government furnished, necessary to keep both units 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 analyzers 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, work flow commensurate to patient volume, and meet space requirements as outlined in paragraph 1.1.1.2. 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 633d Medical Group, Pathology Flight, Joint Base Langley-Eustis (JBLE), VA, Langley Air Force Base (LAFB) division, 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 CAP, Food and Drug Administration (FDA), The Joint Commission (TJC), the Health Services Inspections (HSI) as well as the current United States Air Force (USAF) Referral Management Guidelines. All references within this document stated as singular analyzer, analyzers or system within this PWS applies to, includes requirements for, or covers the two (2) Coagulation Analyzers required by this PWS/contract. 1.1. DESCRIPTION OF SERVICES. 1.1.1. Installation: Placement and installation of the two (2) Coagulation Analyzers and all equipment components inclusive, but not limited to, all laboratory associated mechanical, electromechanical parts and supplies. Installation shall meet or exceed all applicable codes to include Local/State Regulations, National Fire Protection Agency (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 required technician to perform correlation and validation. The contractor shall provide all validation reagent/materials needed to perform these tasks. The contractor shall have certified electrician and engineering specialists on site when the Coagulation Analyzers are delivered for proper equipment installation. 20 March 2020 1.1.1.2. The contractor shall provide an Uninterrupted Power Supply (UPS) per analyzer 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 Coagulation Analyzer system remains operational. The overall approximate measurement of the analyzer is below: a. Dimensions: 22.5 inches x 19.5 inches x 19.5 inches b. Lab table weight allowance: no more than 94.6lbs 1.1.1.3. The contractor shall repair any damage incurred during installation to walls, floorings, ceiling, etc…In addition the contractor shall remove and dispose of any debris associated with the installation. 1.1.1.4. The contractor is responsible for the removal of the analyzers at the end of the contract period or at the government’s discretion. 1.1.2. Analyzer: 1.1.2.1. The contractor shall provide an analyzer that meets the requirements stated in Appendix A, the performance characteristics for accuracy and precision as well as compatible with the Hospital Information System (HIS)/Laboratory Information System (LIS). The analyzers shall meet the following criteria: 1.1.2.2. Analyzers and assays: Analyzers and assays shall be FDA approved (the contractor must provide proof of certification). The assay, analyzers, or company (contractor) cannot have FDA warning letters issued over the past 24 months. 1.1.2.2.1. Have function as an automated, walk-away analyzer for plasma samples from specimen vials or tubes with a single aspiration pathway used for automated and manual sample introduction. See Appendix A. 1.1.2.2.2. The system must use a digital bar code technology to read labeled sample tubes and positive tube identification. Barcode must be read before, during and after aspiration of sample. 1.1.2.2.3. The system can run a Prothrombin Time (PT), Partial Thromboplastin Time (aPTT), Fibrinogen, and an automated D-Dimer available to meet or exceed the CLSI recommendations of a negative predictive value of greater than or equal to 98% and a sensitivity of greater than or equal to 97% for non-high pretest probability of VTE (venous thromboembolism). 1.1.2.2.4. The system must have an on-board algorithm that uses flagging to minimize bias. 1.1.2.2.5. System must require no more than thirteen (13) reagents to minimize reagent inventory management. 1.1.2.2.6. All reagents must be no larger than 10L, without requiring a water supply. 1.1.2.2.7. Must have the ability to change all reagents “on the fly” while analyzer is running. 20 March 2020 1.1.2.2.8. Must have an auto-dilution function for accurate measurement of abnormal fibrinogen or D-dimer levels. 1.1.2.2.9. The system must have zero hands on routine daily maintenance. 1.1.2.3. Analysis System Software: 1.1.2.3.1. The system shall offer customizable repeat/reflex testing automatically, without operator intervention. 1.1.2.3.2. The system shall be capable of on-board decision rules customized to give operators with “if, then” statements to standardize actions for various result scenarios. 1.1.2.3.3. The system shall be capable of onboard reagent tracking to monitor lot numbers, expiration dates and volumes. 1.1.2.3.4. The system provides on board documentation of quality control (QC) results and actions taken for outliers with electronic archiving and corrective action documentation as well as the ability to store multiple lots of quality control results. 1.1.2.3.4.1. Ability to run new and old lot numbers of QC concurrently for parallel testing. 1.1.2.3.4.2. Ability to use only one printer to print and evaluate QC/patient data, review screens, or print files while analyzing patient samples. Printable QC results shall include meaningful information, such as Standard Deviation Index. 1.1.2.3.4.3. Ability to review abnormal results on the analyzer. 1.1.2.4. Information Management System must be able to provide: 1.1.2.4.1. Three (3) different levels of User Access for security of data and system configuration; numeric patient results, graphic results; an unlimited number of user-definable control files; an unlimited number of patient control files; setup of files for each shift worked; record reagent information and lot numbers with autostop in the event of unacceptable QC data if available. 1.1.2.4.2. Entry of control data from diskette or USB ports 1.1.2.4.3. Information Management System with short term storage for: startup log, calibration, reproducibility, carryover, maintenance and system events. 1.1.2.5. Bi-directional transmission of patient results, control results, numeric and graphic to a host computer. 1.1.2.6. Ability to locate patient samples using patient name, SSN, or unique ID, and determine when results will be available. Must meet these specifications for bar code readers and labels: 20 March 2020 Alphanumeric capability; Check sum digit; Code 39; Codabar; Interleaved 2 of 5; Code 128. Have two (2) identification fields, each of which can be alphanumeric or alpha or numeric up to 16 characters. 1.1.2.7. Ability to print patient reports, in a chartable/medical record format, that may be sent to providers during HIS/LIS downtime. Ability to retransmit results after HIS/LIS downtime. The analyzer shall require only one interface. The analyzers shall be able to retransmit data after analyzer downtime. 1.1.2.8. Must have fail-safe sample management system: Positive tube identification (tube barcode read at time of aspiration); Positive position identification (position bar-code read at time of aspiration if available). 1.1.2.9. Require minimal time to perform recurring maintenance (daily, weekly, monthly, etc.). Responses shall indicate the total downtime for each task, not just the hands-on time. 1.1.2.9.1. Require minimal start up time from standby mode to operation. 1.1.2.9.2. Require minimal reagent and calibration preparation. Responses shall include requirements for each. 1.1.2.9.3. System shall have detector system for bubbles, clots, and incomplete sample aspirations. System should be available for detecting interfering substances. 1.1.2.9.4. Include on-board electronic operating manuals and troubleshooting guides as well as a preventive maintenance guide and log. 1.1.2.10. System shall be totally self-contained excluding waste and will not require external water, pressure or vacuum. Vendor shall provide a waste stream analysis for each proposed analyzer and inform the government/FRED if any waste requires special handling before disposal. 1.1.2.11. System shall be calibrated on assayed material compatible with CAP guidelines. The analyzers shall compile all calculations. Calibration and daily QC factors shall be stored internally and activated internally at the operator’s discretion. 1.1.2.12. System must meet performance (precision, linearity and operating ranges) characteristics as specified in Appendix A. 1.1.2.13. Analyzer(s) will include pre-analytical/post-analytical system. 1.1.2.14. Provides Price-Per-Test pricing for 100% of tests listed in Appendix A which shall include the price associated with consumables such as reagents, standards, supplies, consumable/disposable items, QC materials, parts, accessories and any other item required for the proper operation of the contractor’s equipment. 20 March 2020 1.1.3. Service/Recurring/Corrective/Preventive Maintenance (PM’s): The contractor shall perform all required preventative maintenance. The use of the Coagulation Analyzers shall cover the range of services provided in a civilian medical treatment facility and all associated maintenance. 1.1.3.1. Scheduled preventative maintenance calls shall occur at a frequency to meet minimum manufacture’s requirements 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 written report shall be provided to the BMET department and laboratory department, detailing each on-site service incident and repairs made. The contractor’s Field Service Report (FSR) shall provide written documentation of each PM visit as to items performed during the PM 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. 1.1.3.4. Repair actions by contractor personnel shall be continuous until repair is complete unless parts are unavailable. Upon completion of repair activity, the contractor shall consult with equipment operators regarding equipment performance. 1.1.3.5. Perform operational checks on all systems and correct noted deficiencies. 1.1.3.6. Replace worn or defective parts that may fail before the next PM. 1.1.3.7. 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. 1.1.3.8. 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: Contractor shall provide Quality Customer Service: 1.1.4.1. 24/7 technical phone support services and emergency service calls. 1.1.4.2. Technical specialist support, including method validation and onsite training. 1.1.5. Training: Provide training for government personnel (minimum 2 slots implementation year per analyzer module if available) and 1 training slot per analyzer with each option year exercised (if available). 1.2. GENERAL INFORMATION. 1.2.1. Contract Manager. 20 March 2020 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 three (3) 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 633d Medical Group Medical Treatment Facility weekdays between 0730 – 1630, unless an emergency situation arises. 1.2.2.1. Technical Service Assistance Availability. The contractor shall provide service and maintenance assistance to include, but not limited to, Monday through Friday coverage from 7:00 A.M. - 7:00 P.M, to include on-call services during weekends and holidays, and a 24 hour Call Center and/or Consult access and availability. 1.2.2.2. Emergency Service Calls. 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 service calls shall be the responsibility of the contractor. 1.2.2.3. Response time to emergency service requests shall not exceed 24 hours, including weekends and holidays or as needs arise. 1.2.2.4. The equipment shall be repaired within 24 hours after arrival at the equipment site, excluding holidays and weekends. The need for unavailable parts will suspend the time limit until parts are obtained. 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. 20 March 2020 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 633 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 633d 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 nongovernment 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. 1.2.9.1. Base Passes. 1.2.9.1.1. Contractor personnel shall obtain base passes for entry onto JBLE in compliance with AFI 10-245, Antiterrorism (AT), 21 September 2012. 20 March 2020 1.2.9.1.2. Base passes are issued for a maximum of 180 days, and must be renewed every 180 days. 1.2.9.1.3. A minimum of 15 days notice is required to obtain base passes. The contractor must submit the following pertinent information to the 633d Medical Logistics not 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 1.2.9.2. Exclusions. Contractor personnel are not authorized entry to Joint Base Langley-Eustis (JBLE) 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 1.2.9.3. In addition, contractor personnel are not authorized entry to JBLE 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 20 March 2020 1.2.10. Accident Reporting. The contractor shall report all occupational exposures and all accidents while on duty at the 633 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. 1.2.11. Traffic Laws. The contractor shall comply with the installation traffic code as specified in Virginia State Law and AFI 31-218, Motor Vehicle Traffic Supervision, and may be subject to search prior to authorization to proceed through gate. 1.2.12. Weapons, Firearms, and Ammunition. Contractor personnel are prohibited from possessing weapons, firearms or ammunition, on themselves or within their contractor-owned vehicle or privately-owned vehicle while on JBLE. 1.2.13. Smoking in ACC Facilities. Contractors are advised that the Air Combat Command (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. Contractor personnel and visitors are subject to the same restrictions as government personnel. Smoking is permitted only in designated smoking areas. Hospital campus is totally smoke free. 1.2.14. 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. 1.2.15. 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. 1.2.16. Inventory. Within ten (10) days of contract start, the contractor and the government shall conduct an inventory of all items used on JBLE, VA. A semi-annual inventory will be conducted on the analyzers between the MTF 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. 20 March 2020 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. 20 March 2020 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 two (2) Coagulation Analyzers 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 Coagulation Analyzers are delivered for proper equipment installation. 1.1.1.1. 100% Initial (100%) Surveillance 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 Surveillance SERVICE/ PREVENTIVE/ CORRECTIVE MAINTENANCE 20 March 2020 SS#5 - Provides service and Preventive Maintenance assistance to include, but not limited to, Monday through Friday coverage from 7:00 A.M. - 7:00 P.M, to include, but not limited to, on-call services during weekends and holidays, and a 24 hour Call Center and/or Consult access and availability. 1.1.3. 1.2.2.1. 100% Periodic Surveillance Customer Complaint SS#6 – Furnish and install all software updates and equipment modifications provided by the manufacturer at no additional cost. 1.1.3.7 100% Periodic Surveillance SS#7 – Provides analyzers that must meet the requirements stated and performance characteristics defined by CLIA’88 & CLSI 1.0. 100% Periodic Surveillance SS#8 – Provides analyzers and assays that are FDA approved and have no FDA warning letters issued over the past 24 months. 1.1.2.2. 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 – Provides supplies and reagents for 100% tests listed in Appendix A 1.1.2.14. 100% Periodic Surveillance SS# 11 - Contractor shall provide Quality Customer Service: Quality of 24/7 Technical Phone Support services and Emergency service calls to include method validation and onsite training. 1.1.4. – 1.1.4.2. 100% Periodic Surveillance Customer Complaint SS# 12 - Provide training for government personnel as required by the PWS. 1.1.5. & 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 Coagulation Analyzers shall cover the range of services provided in a civilian medical treatment facility with all associated maintenance. 1.1.3. 100% Periodic Surveillance 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 20 March 2020 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 Coagulation Analyzers, 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 Coagulation 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. 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 to the CO for review and feedback NLT 30 days after contract 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 record...