Attachment 1 Hematology Statement of Work.docx

SECTION 1

SCOPE OF WORK

1.0. SCOPE OF WORK: This is a firm fixed price cost per test contract to provide. The 633rd Medical Group, Langley AFB, VA requires two upright fully automated Hematology System that can perform all its necessary hematology testing assays. The Laboratory requires a solution for complete blood count (CBC) testing, body fluid testing, a slide maker/stainer, and a slide reader. The system must integrate with current LIS system, QC lockout, automated QC, calibrations and dilutions, no sample carryover, sample management, 24hr operational, positive patient identification and on-board storage for reagents.

**% is for actually number of the cell count. # is for the absolute number** Essential Characteristic

· Function correctly in an ambient temperature of 15°C to 32°C (59°F to 89°F) with a relative humidity of 20% to 95% (non-condensing).

· Analyzers shall an integrated hematology system.

· Analyzers shall have an approved ATO.

· Analyzers and assays shall be FDA approved. The assay, instrumentation or the company cannot have FDA warning letters issued over the past 24 months.

· Analyzers shall fit in space of a 41.5-inch width, a 61.7-inch height, and 38-inch depth.

· Line system shall fit in space of 36-inch width, 37-inch height, and 35-inch depth.

· Instruments should interface with the laboratory Genesis laboratory information management system (LIMS).

· Analyzer must require aspiration volumes of no more than 88 µl to perform full hematology reportable test profile (CBC with fluorescent NRBC count, 6-part fluorescent differential and fluorescent reticulocyte count).

· Must include a pre-dilute sample access mode which requires lower sample volume (70 µl aspiration) to perform full hematology reportable test profile.

· Must be able to provide a fully integrated co-primary system capable of workload balancing and maximizing efficiency by operating two analyzers simultaneously.

· Analyzer to analyzer correlation specifications must be provided.

· Must have the capability to operate in a single tube mode and automated rack mode simultaneously.

· The system must be capable of utilizing sample tube bare codes for accurate sample identification.

· Must offer the option of automatic rerun/reflex testing on a different, connected analyzer.

· Must offer reagent storage wagons that contain reagents and pneumatic unit associated with analyzers.

· Must have walk away shut down and restart capability.

· All solutions must offer ability to ‘load and go’ where sample barcodes do not need to be pre-aligned before analysis.

· Analyzers software must have pre-defined, editable rule set on board software.

· Pre-defined on-board rule sets must indicate ISLH (International Society for Laboratory Hematology) specific rules.

· Must offer pre-defined and user-definable rules options for body fluid samples.

· Software database must hold a minimum of 100,000 analysis data.

· Must have a single aspiration pathway eliminating the need for mode-to-mode QC and/or calibration.

· Instrument must be able to stop performing patient’s sample if QC fail.

· Must offer fully reportable, FDA cleared immature granulocyte providing a 6-part differential.

· Must offer fully reportable, FDA cleared RET-He.

· Must offer fully reportable, FDA cleared IPF.

· Must offer fully reportable, FDA cleared PLT-F.

· Must provide enhanced body fluid testing capability using fluorescent flow cytometry.

· Must be able to analyze and report results from the following type of body fluids: Serous, synovial and CSF.

· Must provide a WBC, RBC and Total nucleated count with a 2-part differential (polymorphonuclear %/# (and mononuclear %/#) with every body fluid analysis. (%/# = % is presenting number of the cell count. And # is presenting the absolute number - the calculation of the total WBC and the cell count).

· Must offer a separate mode on system for the analysis of body fluids.

· Must be able to qualitatively indicate (via suspect flag) cell abnormalities with body fluid samples.

· Must be able to report RBC and WBC data to three decimal places within the body fluid mode.

· Must provide a fluorescent NRBC count with every CBC analysis.

· Must directly measure HCT.

· Must use non-cyanide reagent for Hgb.

· Must combine flagging information from multiple channels to optimize diagnostic information.

· Must offer customizable suspect flags settings to optimize review rates.

· Reagent packs must perform at least 500 tests per container.

· Reagent containers must have at least 60 days open stability on all reagents.

· Single control must provide measurements for all whole blood parameters on system.

· Control must have minimum dating of at least 78 days.

· Must have control offering specific for body fluid count reporting.

· QC peer group data must have real time, automatic electronic data upload capability to analyzer quality control.

· Must offer on-board reagent monitoring.

· Must offer reagent inventory management.

· Must provide 24-hour, 7-days a week immediate access to QC peer review data.

· Slide preparation instrument must offer flexibility to operate in automation mode (rack) or manual mode with ability to use multiple tube sizes (microtainer samples).

· Slide preparation instrument must have the ability to reduce hazardous waste by re-using stain and methanol.

· Must provide automated cleaning mode where operator involvement is minimal <15 minutes per 24 hours.

· Must include an open reagent system that provides options for laboratory for different types of stain and buffers to use for system.

1.1. INSTALLATION.

1.1.1. Installation: Placement and installation of a hematology analyzer and all equipment components include, but not limited to, all laboratory associated mechanical, electromechanical parts and supplies to include supplies needed to support the overlap of new and old equipment during the validation process of the new equipment. 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 have all required technicians and specialists on site when the hematology analyzer is delivered to ensure correct 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 hematology analyzer system remains operational. The UPS overall measurement and rear clearance for connection is no more than 444.5 x 741 x 130.6 cm and weigh no more than 70 kg, with a minimum clearance of 102 mm on all 4 sides for proper ventilation.

1.1.1.3. The contractor shall complete clean-up (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 shall provide a project manager to perform/oversee system installation and required technician and specialist to perform correlation and validation. The contractor shall provide all validation reagent/materials needed to perform these tasks. A field specialist will be on site to run precision linearity and method comparison studies. Data will be analyzed and submitted to the Medical Director for approval. The contractor will conduct normal range studies.

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

1.2. ANALYZER:

1.2. The system can run a CBC w/o Diff, CBC w/Diff, Reticulocyte count panel, white blood cell differential, nucleated red blood cell count, platelet count, White blood cell morphology, Red Cell morphology, Platelet morphology, CSF and other body fluid cell count.

1.2.1. The contractor shall provide an analyzer that meets the requirements stated in Technical Exhibit and the performance characteristics for accuracy and precision.

TECHNICAL EXHIBIT

WBC

RBC

HGB

HCT

MCV

MCH

MCHC

PLT

RDW

MPV

NEUT%/#

LYPMH%/#

MONO %/#

BASO%/#

IG%/#

NRBC%/#

WBC-BF

RBC-BF

TC-BF

MN%/#

PMN%/#

RBC

Retic%/#

RET-He

1.2.2. Analyzer and assays shall be FDA approved (the contractor must provide proof of certification). The assay, instrumentation or the contractor cannot have FDA warning letters issued over the past 24 months. The analyzers shall meet the following criteria:

1.2.2.1. Function as an automated, walk-away instrument for hematology analysis.

1.2.2.2. Provide Automated Hematology analysis for white cell count, white cell morphology, red cell count, red cell morphology, platelet count, platelet morphology, CSF cell count, Synovial and other body fluid cell count.

1.2.2.3. Provide Hematologic calculations of the following: hemoglobin (HGB), hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), platelets (PLT), neutrophil (NEUT)%/#, lymphocyte (LYMPH)%/#, monocyte (MONO)%/#, eosinophil (EO)%/#, basophil (BASO)%/#, immature granulocytes (IG)%/#, red cell distribution width coefficient variation (RDW-CV), red cell distribution width standard deviation (RDW-SD), mean platelet volume (MPV), nucleated red blood cells (NRBC)#/%, reticulocyte (RET)%/#, immature platelet fraction (IPF), immature reticulocyte information (IRF), reticulocyte hemoglobin (RET-He), white blood count body fluid (WBC-BF), red blood count body fluid (RBC-BF), mononuclear (MN)%/#, polymorphonuclear (PMN)%/#, and total cell count body fluid (TC-BF) parameters.

1.2.2.4. Provide a unified platform connected by a track that incorporates hematologic analysis platforms and Bidirectional connectivity with MHS Genesis.

1.2.2.5. Provide reagent barcode capability and inventory control, to include data archiving and active reagent volume monitoring and warning. Reagents shall have extended calibration stability.

1.2.2.6. Read bar coded patient samples using the Universal Identification system and can enter/run patient samples manually, with or without barcodes, during Healthcare Information System (HIS)/Laboratory Information System (US) downtime.

1.2.2.7. Minimize sample carryover: Carryover specifications shall be provided for each instrument.

1.2.2.8. Include a multi-tasking computer system with:

1.2.2.8.1. User-friendly/windows-based software, which operators of all skill levels should be able to use efficiently. The contractor shall demonstrate the operation of the software and equipment to government personnel.

1.2.2.8.2. Ability to locate patient samples using patient name, Social Security Number (SSN), or unique identification (ID), and determine when results shall be available.

1.2.2.8.3. Ability to print patient reports in a chartable/medical record format that may be sent to providers during HIS/US downtime.

1.2.2.8.4. Ability to retransmit results after HIS/LIS downtime.

1.2.2.8.5. Ability to easily add/update quality control and calibrator materials and values and track the changes.

1.2.2.8.6. Ability to run new and old lot numbers of Quality Control (QC) concurrently for parallel testing.

1.2.2.8.7. Ability to use only one printer to print QC data, review screens, or print files while running patient samples.

1.2.2.8.8. Ability to review abnormal results on the instrument.

1.2.2.8.9. Include an interactive, on-board QC package with:

1.2.2.8.9.1. Modified Westgard rules and Levy-Jennings plots.

1.2.2.8.9.2. Printable QC results that include meaningful information, such as Standard Deviation Index.

1.2.2.8.9.3. Electronic archiving and corrective action documentation.

1.2.2.8.9.4. Ability to evaluate and print QC results while the instrument is analyzing patient samples.

1.2.2.8.9.5. Ability to monitor calibrations for slope, intercept, and blank.

1.2.2.8.9.6. Ability to export values to the contractor for a monthly statistical report (quality control program)

1.2.2.9. The instrument shall require only one interface.

1.2.2.10. Provide true Stat/immediate interrupt.

1.2.2.11. Offer a total sample output of 100 samples per hour.

1.2.2.12. Require minimal time to perform recurring maintenance (daily, weekly, monthly, etc.). Contractor shal1 indicate the total downtime for each task, not just the hands-on time.

1.2.2.13. Require minimal start up time from standby more to operation.

1.2.2.14. Require minimal reagent and calibration preparation. Responses shall include requirements for each.

1.2.2.15. System shall have detector system for bubbles, clots, and incomplete sample aspirations. System should be able to detect interfering substances.

1.2.2.16. System must have a cleansing mechanism for small clots, electronic cleansing mechanism preferred.

1.2.2.17. Include on-board electronic operating manuals and troubleshooting guide as well as a preventive maintenance guide and log.

1.2.2.18. Ensure ease of calibration with extended calibration stability and minimal calibration frequency.

1.2.2.19. System shall be totally self-contained excluding waste and shall not require external water, pressure, or vacuum. Vendor shall provide a waste stream analysis for each proposed instrument; and inform the Functional Requirements Evaluator Designee (FRED) if any waste requires special handling before disposal.

1.2.2.2. System shall be calibrated on assayed material compatible with the CAP guidelines. The analyzer shall compile all calculation. Calibration and daily QC factors shall be stored internally and activated internally at the operator's discretion.

1.2.2.2.1. System shall have the capability to store up to a combined total of 10,000 Patient and QC files for later recall. Contents of the patient files shall include hematology results and the actual WBC scattergram images that can be viewed on demand.

1.2.3. The contractor shall provide all validation reagents/materials needed to perform verification and validation.

1.3. Preventive/ Corrective Maintenance (PM's): The contractor shall perform all required preventative maintenance. The use of the hematology analyzer shall cover the range of services provided in a civilian medical treatment facility with all associated maintenance.

1.3.1. Scheduled preventative maintenance calls shall occur at a frequency to meet minimum manufacturer's requirements to keep the instrument in optimal operating condition. The contractor shall coordinate service calls with the MTF Biomedical Maintenance (BMET)

1.3.2. A written report shall be provided to BMET and laboratory 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.

1.3.3. The contractor shall provide a company service technician for on-site support services available to respond when services are required to include the overlap of new and old equipment during the validation process of the new equipment.

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.

1.3.5. Perform operational checks on all systems and correcting noted deficiencies.

1.3.6. Replace worn or defective parts (those parts that may fail before the next PM). Replace worn or defective parts only with new Original Equipment Manufacturer (OEM) parts to include the overlap of new and old equipment during the validation process of the new equipment.

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 and installed no later than the next PMI or visit.

1.3.8. Equipment malfunctions. During regular and after duty hours, all equipment malfunctions will immediately be brought to the attention of the BMET. After which, the Lead Technician on duty shall then place a technical service call to the contractor.

1.4. Corrective Maintenance:

1.4.1. 24/7 technical phone support services and emergency service calls that meets the 24-hour turnaround time.

1.4.2. Quality technical specialist support, including method validation and onsite training.

1.4.3. The vendor shall provide OEM-trained, experienced, English-speaking personnel. The Vendor shall provide all labor, tools, diagnostic equipment, software, material, supplies, transportation, parts, and equipment necessary to perform Preventive Maintenance (PM), Calibration (CAL), Safety Testing (ST), and corrective maintenance.

1.5. Training. Provide training for government personnel (minimum 2 slots implementation year per analyzer module) and l training slot per instrument with each option year exercised.

1.6. General Information:

1.6.1. Contract Manager.

1.6.1.1. The contractor shall provide a point of contact information for the contract manager and an alternate. 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.

1.6.1.2. 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.

1.6.1.3. Hours of Operation. Normal delivery time of supplies and reagents shall be at the 633d Medical Group Medical Treatment Facility between 0730-1630, Monday thru Friday, unless an emergency arises.

1.6.1.4. Technical Service Assistance Availability. The contractor shall provide 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 on-call services during weekends and holidays, and a 24-hour Call Center and/or Consult access availability.

1.6.1.5. 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 onsite 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.

1.6.1.6. Response time to emergency service requests shall not exceed 24 hours, including weekends and holidays or as needs arise.

1.6.1.7. 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.

1.6.1.8. Performance During Crisis. 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 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.

1.6.1.9. English Language Requirement. The vendors ‘personnel should read, understand, speak, and write English fluently.

1.7. Identification Badge: Contractor personnel shall always display a contractor badge and in plain view.

1.7.1. 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 in compliance with state and local Jaws. 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 this is not accomplished.

1.8. Base Passes:

1.8.1. Contractor personnel shall obtain base passes for entry onto JBLE in compliance with AFI 10-245, ACC Supplement l.

1.8.2. Base passes are issued for a maximum of 180 days, and must be renewed, when necessary. The contractor must submit the following pertinent information to the sponsoring agency:

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. Date of pass expiration

1.8.2.1. 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.

Note(*): Subjects convicted of murder, aggravated sexual assault or rape, or child molestation may appeal the denial of base access to the Commander, 633d Air Base Wing.

1.8.2.2. In addition, contractor personnel are not authorized entry to JBLE if they have been convicted of any of the following offenses within the previous 5 years:

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

1.8.3. Accident Reporting. The contractor shall report all occupational exposures and all accidents while on duty at the MTF resulting in death, trauma, or occupational disease to the COR. All accidents shall be repo1ted within 24 hours of their occurrence. The CO or COR 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.

1.8.4. Traffic Laws. The contractor and/or contractor personnel shall comply with the installation traffic code as specified in Virginia State Law and Air Force instruction (AFI) 31-2 I 8, Motor Vehicle Traffic Supervision (current edition) and may be subject to search prior to authorization to proceed through gate. The contractor and/or contractor personnel shall comply with current instruction on cell phone use while on a military installation.

1.8.5. 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 Joint Base Langley-Eustis (JBLE).

1.8.6. 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. AFT 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. The 633 Medical Group hospital campus is totally smoke free.

1.8.7. 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 its terms and conditions. It is the contractor's responsibility to ensure their contractor personnel are familiar with and understand the contents of this SOW as well as the company's handbooks/handouts, etc. prior to beginning work at this MTF.

1.8.8. 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.

1.8.9. Inventory. Within ten (10) days of contract start or a new period of performance, the contractor and the government will conduct an inventory of all items related to this contract. A semi-annual inventory will be conducted on the analyzer between the MTF and the contractor.

2. GENERAL DEFINITIONS. The following terms shall have the meaning set forth in accordance with the terms of this SOW.

2.1. COMMANDER. MTF Commander, Flight Commander or other leader or a designated representative, e.g., Department Chairperson of the activity designated in this contract.

2.2. 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.

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

2.4. MEDICAL TREATMENT FACILITY (MTF). Air Force hospitals or clinics, including all activities providing outpatient and/or in-patient healthcare services for authorized personnel.

2.5. QUALITY ASSURANCE PROGRAM. 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.

2.6. 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.

2.7. 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.

3. PERFORMANCE EVALUATION. The purpose of the SS is to define performance evaluation. The Performance Objective (column l) 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.

Performance Objective (The Service required—usually a shall statement from Part 5)

Performance Requirements Summary (PRS) # 1.

The contractor shall provide Placement and installation of one Integrated Hematology Analyzer, DIFF line system 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

PRS # 2

The contractor shall have electrician and engineering specialists on site when the Integrated Hematology Analyzer is delivered for proper equipment installation SOW Part 1.

Section 1.1.1.1

PRS # 3

The contractor shall provide the required UPS SOW Part 1.

Section 1.1.1.2

PRS # 4

Complete clean-up of the work area during installation SOW Part 1.

Section 1.1.1.3

Section 1.6.1.4

Section d.

Section 1.2.2

Section 1.1.1.4

Section 1.2.1.

Customer Compliant

Section 1.4.1.

Customer Compliant

Section 1.5 Section 4. e

Customer Compliant

Section 1.4.4

3.1 The government reserves the right to inspect throughout all phases of site preparation and construction prior to delivery and installation of the Hematology Analyzer, post installation and for functionality prior to patient encounters.

3.2. 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 supplies and 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.

3.3. 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. When the defects in services cannot be corrected by reperformance, the government may (l) 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) terminate the contract for default.

3.4. 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 LT 30 days after contract award. 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:

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

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

3.7. Quality Assurance. The government shall inspect and evaluate the contractor's performance to ensure services are received IA W 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 performance meets the standards contained in this PWS. Only one (l) 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 Defense Health Agency 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.

3.8. 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.

3.9. 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 nonconsecutive months in any period, could result in a warning or letter of concern from the CO.

3.10. Surveillance Methods.

3.10.1. 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.

3.10.2. Customer Complaint. This method requires the 633rd MDG 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 office within five (5) calendar days of receipt. Any unsatisfactory inspection identified but re-performed acceptably will still be counted as an unsatisfactory inspection.

3.10.3. Performance Evaluation Meetings. The CO, DHA Director, 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 633rd MDG customer complaints and provide insight into any identified trends.

3.10.4. The minutes of these meetings will be reduced writing, signed by the CO and any other signatures as deemed appropriate, 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.

4. DELIVERABLES

a. All validation reagent/materials needed to perform the services within this contract.

b. Scheduled preventative maintenance calls at a frequency to meet minimum manufacturer’s requirements.

c. Service calls/Corrective actions with a written report provided to BMET and laboratory detailing each on-site service incident and repairs made.

d. Furnish and install all software updates and equipment modifications provided by the manufacturer.

e. Training to government personnel

5.0. GOVERNMENT FURNISHED PROPERTY, EQUIPMENT, SUPPLIES AND SERVICES

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

5.1.2. Shall have adequate facilities and equipment for the safe and effective operation of such analyzer.

5.2. Special procedures shall be established for the handling and processing of biohazard materials.

5.3. Emergency Health Care. The MTF will provide emergency health care for contractor providers for injuries incurred while on duty in the MTF. These services will be billed to the contractor at the current full reimbursement rate. An option is available for the worker to refuse MTF care and go to a healthcare facility covered by their insurances.