Attachment 1 PWS Revised 03Mar2021.pdf

PERFORMANCE WORK STATEMENT (PWS)

For

DGMC 60 MDTS/SGQC

AUTOMATED MICROBIOLOGY IDENTIFICATION (ID)

& ANTIBIOTIC SUSEPTIBILITY TESTING (AST)

03 MARCH 2021

Part 1

General Information

1. GENERAL: This is a non-personnel services contract to provide Automated Microbiology Identification and Antibiotic Susceptibility Testing The Government shall not exercise any supervision or control over the contract service providers performing the services herein. Such contract service providers shall be accountable solely to the Contractor who, in turn is responsible to the Government.

1.1. Description of Services/Introduction: The contractor shall provide all reagents, testing systems, equipment, personnel, transportation, materials, supervision, maintenance of all equipment, training and other items and all other items necessary to perform Automated Microbiology and Antibiotic Susceptibility Testing as defined in the Performance Work Statement. Except for those items specified as government furnished property and services. The contractor shall perform to the standards in this contract.

1.2. Background: The service contact will provide means to identify antimicrobials and streamline susceptibility testing. This feature will provide information about the characteristics of bacterial isolates to antibiotics. Physicians rely heavily on this information to make accurate treatment decisions for patients who have bacterial infections. This analyzer is an indispensable part of patient care at David Grant Medical Center.

1.3. Objectives: Must provide a test system at David Grant Medical Center for the 60TH MDTS/SGQC DGMC Laboratory staff to use. The analyzer(s) must meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA). Data quality for the US Food and Drug Administration (FDA) released library must have a correct Species/Complex ID rate of greater than or equal to 95% for routine organisms, as demonstrated by the FDA 510K Summary. Equipment must function with a 95% up-time and ability to perform patient testing.

1.4. Pre‐Market Approval: Section 510(k) of the Food, Drug and Cosmetic Act requires In Vitro device manufacturers to register with the FDA at least 90 days in advance of their intent to market a medical device. This is known as Premarket Notification ‐ also called PMN or 510(k). Must be in compliance with Section 510(k) of the Federal Food, Drug, and Cosmetic Act for those medical device products intended to be delivered to the Government. Only devices that have received Premarket Notification Approval from the FDA shall be considered for award under this solicitation.

1.5. Scope: Automated Microbiology Identification and Antibiotic Susceptibility Testing. The Contractor shall provide all management, tools, parts, materials (including all reagents, quality control materials, and consumable parts and accessories), equipment, travel, and labor necessary to provide the instrumentation described in appendix A for the Clinical Lab located at David Grant Medical Center (DGMC), Travis AFB. Services include instrument use, preventive maintenance, troubleshooting guidance, 24/7 telephone service as well as response by a technical expert provided by the contractor 5 days per week (Monday thru Friday), excluding Federal Holidays and calibration services at frequencies specified in the manufacturer’s service and operations manuals as well any required intervening repair service requirements for the entire contract period, including options if exercised. Expedited shipping options, to include overnight, should emergent supply needs arise. All patient and testing information must be accessible and accurate. All services provided shall be performed in accordance with all applicable laws, regulations, standards, local instructions, and commercial practices.

1.5.1. The contract pricing must be an all-inclusive price with-in the Cost Per Test (CPT)

1.6. Period of Performance: The period of performance shall be for one (1) Base Year of 12 months and four (4) 12-month option years. The Period of Performance reads as follows:

Base Year 1 June 2021 – 31 May 2022 Option Year I 1 June 2022 – 31 May 2023 Option Year II 1 June 2023 – 31 May 2024 Option Year III 1 June 2024 – 31 May 2025 Option Year VI 1 June 2025 – 31 May 2026

1.7. General Information

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

1.7.2. Recognized Holidays: Contractor will provide onsite service 5 days a week (Monday thru Friday) to exclude the holidays listed below:

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

1.7.3. Hours of Operation: The contractor is responsible for conducting business, between the hours of 8:00 am to 4:00 pm, Monday thru Friday except Federal holidays or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings. For other than firm fixed price contracts, the contractor will not be reimbursed when the government facility is closed for the above reasons. The Contractor must at all times maintain an adequate workforce for the uninterrupted performance of all tasks defined within this PWS when the Government facility is not closed for the above reasons. When hiring personnel, the Contractor shall keep in mind that the stability and continuity of the workforce are essential.

1.7.4. Instrument Repair and Maintenance: Equipment daily maintenance requirements shall not exceed 10 minutes at a minimum, the contractor will provide the following maintenance and repair services:

• Must provide onsite maintenance (monthly, quarterly, annually, etc.) in accordance with manufactures guidelines every year of the contract.

• Must provide all required tools, parts and labor as necessary to keep the instrument operational.

• Must provide over the phone, instrument technical support during normal duty hours (Monday through

Sunday 24 hours per day 7 days per week).Must provide onsite technical support 8 hours per day 5 days per week every year for the length of the contract, excluding federal holidays.

• The contractor will monitor equipment to ensure instrument downtime will not exceed 48 hours for a single occurrence.

• In the event of an instrument failure, the contractor will provide a solution within 48 hours.

• The contractor is responsible for all tools, parts, travel/lodging and labor that are necessary to bring the instrumentation back online within 48 hours from the initial service call.

1.7.5. Service Reporting: During any On-site visit, contractor shall furnish a legible service report after to the Medical Equipment Repair Center (MERC) personnel, signed off by the department, including the date, time, company name and service representative, contract number, description of malfunction, description of any services performed, and any recommendations necessary to maintain equipment in the best operating condition.

1.7.6. Place of Performance: The work to be performed under this contract will be performed at David Grant Medical Center, Microbiology department, Room 2B302. Once equipment is onsite, initial inspection of contractor owned equipment will be conducted by Biomedical Equipment Maintenance/Repair Section prior to use in Medical Treatment Facility.

1.7.7. Type of Contract: The government will award a Firm Fixed Price Contract.

1.7.8. Security Requirements: Contractor personnel performing work under this contract must be eligible for Military Base access at time of the proposal submission, and must maintain the level of security required for the life of the contract. The security requirements are in accordance with the attached DD254 and Travis AFB Contract Security Requirements dated 29 April 2019.

1.7.9. Post Award Conference/Periodic Progress Meetings: The Contractor agrees to attend any post award conference convened by the contracting activity or contract administration office in accordance with Federal Acquisition Regulation Subpart 42.5. The contracting officer, and other Government personnel, as appropriate, may meet periodically with the contractor to review the contractor's performance. At these meetings the contracting officer will apprise the contractor of how the government views the contractor's performance and the contractor will apprise the Government of problems, if any, being experienced. Appropriate action shall be taken to resolve outstanding issues. These meetings shall be at no additional cost to the government.

1.7.10. Key Personnel: The follow personnel are considered key personnel by the government: Technical Application Specialist, Contract manager/Alternate contract manager. The contractor shall provide a contract manager who shall be responsible for the performance of the work. The name of this person and an alternate who shall act for the contractor when the manager is absent shall be designated in writing to the contracting officer. The contract manager or alternate shall have full authority to act for the contractor on all contract matters relating to daily operation of this contract. The contract manager or alternate shall be available between 8:00 am to 4:00 pm, Monday thru Friday except Federal holidays or when the government facility is closed for administrative reasons.

1.7.11. Identification of Contractor Employees: Service contracts shall require contractor employees to identify themselves as contractor personnel by introducing themselves or being introduced as contractor personnel and displaying distinguishing badges or other visible identification for meetings with Government personnel. In addition, contracts shall require contractor personnel to appropriately identify themselves as contractor employees in telephone conversations and in formal and informal written correspondence. They must also ensure that all documents or reports produced by are suitably marked as contractor products or that participation is appropriately disclosed. Contractor employees will be required to check in with the Medical Equipment Repairs Department and obtain a visitor’s badge prior to entering the Clinical Laboratory.

1.7.12. Phase-In Period: To minimize any decreases in productivity and to prevent possible negative impacts on additional services, the Contractor shall have personnel on board, during the 30 day phase-in out period. The phase-in out period may be extended up to 15 days, but not to exceed 45 days unless mutually agreed upon. During the phase in period, the Contractor shall become familiar with performance requirements in order to commence full performance of services on the contract start date.

1.7.13. Instrument Installation, Validation and Training Support: A factory trained representative of the contractor will install, validate and correlate analyzers per College of American Pathologist guidelines at the company’s expense with results approved by Laboratory Medical Director and Microbiology Technical Supervisor, or designee.

Contractor shall set up and validate custom auto‐verification rules in middleware based on DGMC laboratory specific requirements. Contractor must provide a specialist to perform/oversee system installation, correlation and instrument rule validation prior to live patient testing. Contractor must assist in the acquisition of all specimens required for validation/correlation. Completion and approval of the instrument installation and validation must be performed within 18 business days of contractor onsite, or a predetermined, mutually agreed upon timeframe.

Contractor also provides all validation reagents, calibrators, controls, and consumables needed to perform these tasks free of charge during the validation period. Contractor will provide training and support for automation programming and troubleshooting with equipment. Contractor shall provide initial and recurring training to technicians on instrument use, maintenance, and troubleshooting. Initial training will be provided for a maximum of ten technicians in person on‐site by a factory trained representative. Recurring training shall include, a web‐based training program available on demand, or an equivalent training program accessible throughout the year, and quarterly onsite training. The web‐based training program, or its equivalent, must allow for an unlimited number of trainees to have personalized training plans that are accessed and tracked. Web‐based training, or its equivalent, shall include instructions for operation and maintenance of all included equipment. At least quarterly, the contractor will provide a factory trained representative to provide hands‐ on analyzer training to conduct onsite training for one day. Contractor shall provide comprehensive written operating instructions for all aspects of equipment functions (i.e. routine specimen analysis, calibrations, etc.) and training materials to DGMC equipment operators on the daily, weekly, monthly, and as required maintenance when required or requested by the contracting officer. If the testing capabilities increase beyond the capabilities of the instrument additional instrumentation/training will be provided to continue testing

1.7.14. Equipment Removal: At the end of the contract term, the contractor shall remove all equipment within 60 days after notification of the expiration of the terms of this contract but not until the completion of new contractor’s equipment installation inclusive of completed cross over studies. Contractor shall not remove hard drive from premises. All drives with patients’ information remains the property of the Government.

1.7.15. Contractor Reporting Requirement: For FY 2020, contractors will begin reporting manpower data relating to the performance of services contracts into the System for Award Management.

*Reporting Period: Contractors are required to input data the first quarter of FY21.

1.7.16. Mission Essential Plan: The contractor will submit a Mission Essential Contractor Service Plan that adequately details a realistic approach as to how the contractor will continue to perform the essential contractor services listed in the Performance Work Statement (Attachment 1).Proposed Mission Essential Contractor Service Plans must specifically address each part of the DFARS 252.237-7024 (b)(2)(through v).

PART 2

DEFINITIONS & ACRONYMS

2. DEFINITIONS AND ACRONYMS:

2.1. DEFINITIONS:

2.1.1. CONTRACTOR. A supplier or vendor awarded a contract to provide specific supplies or service to the government. The term used in this contract refers to the prime.

2.1.2. CONTRACTING OFFICER. A person with authority to enter into, administer, and or terminate contracts, and make related determinations and findings on behalf of the government. Note: The only individual who can legally bind the government.

2.1.3. DEFECTIVE SERVICE. A service output that does not meet the standard of performance associated with the Performance Work Statement.

2.1.4. DELIVERABLE. Anything that can be physically delivered, but may include non-manufactured things such as meeting minutes or reports.

2.1.5. KEY PERSONNEL. Contractor personnel that are evaluated in a source selection process and that may be required to be used in the performance of a contract by the Key Personnel listed in the PWS. When key personnel are used as an evaluation factor in best value procurement, an offer can be rejected if it does not have a firm commitment from the persons that are listed in the proposal.

2.1.6. PHYSICAL SECURITY. Actions that prevent the loss or damage of Government property.

2.1.7. QUALITY ASSURANCE. The government procedures to verify that services being performed by the Contractor are performed according to acceptable standards.

2.1.8. QUALITY ASSURANCE Surveillance Plan (QASP). An organized written document specifying the surveillance methodology to be used for surveillance of contractor performance.

2.1.9. QUALITY CONTROL. All necessary measures taken by the Contractor to assure that the quality of an end product or service shall meet contract requirements.

2.1.10. SUBCONTRACTOR. One that enters into a contract with a prime contractor. The Government does not have privity of contract with the subcontractor.

2.1.11. WORK DAY. The number of hours per day the Contractor provides services in accordance with the contract.

2.1.12. WORK WEEK. Monday through Friday, unless specified otherwise.

2.2. ACRONYMS:

AST Antimicrobial Susceptibility Testing ATO Authorization to Operate CAP College of American Pathologist CCE Contracting Center of Excellence CLIA Clinical Laboratory Improvement Act CLSI Clinical Laboratory Standards Institute DD254 Department of Defense Contract Security Requirement List DFARS Defense Federal Acquisition Regulation Supplement DGMC David Grant Medical Center DHA Defense Health Agent DOD Department of Defense

DSN Defense Switched Network FAR Federal Acquisition Regulation FDA Federal Drug Administration FY Fiscal Year HIPAA Health Insurance Portability and Accountability Act of 1996 IAW In Accordance With ID Identification LIS Laboratory Information System MALDI-TOF Matrix Assisted Desorption/Ionization Time of Flight MERC Medical Equipment Repair Center MS Mass Spectrometer MTF Medical Treatment Facility OCI Organizational Conflict of Interest PMN Premarket Notification POC Point of Contact PWS Performance Work Statement QASP Quality Assurance Surveillance Plan QC Quality Control UPS Uninterruptible Power Supply

PART 3

GOVERNMENT FURNISHED PROPERTY, EQUIPMENT, AND SERVICES

3. GOVERNMENT FURNISHED ITEMS AND SERVICES:

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

3.1.1. Utilities: For the purpose of this contract, the government will furnish all required utilities such as water, telephone, electricity, etc. Long distance and Defense Switched Network (DSN) telephone services will be provided for official use only.

3.1.2. Security Forces and Fire Protection: Phone numbers: Non‐Emergency Fire Department: 424‐3683; Non‐ Emergency Security Police: 424‐3293. Emergencies (call) 911.

3.1.3. Emergency Healthcare: The MTF will provide emergency health care to save loss of life or limb and preserve undue suffering for contract personnel for injuries or illness occurring while on duty in the MTF. These services will be billed to the contractor at the current full reimbursement rate through TRICARE.

PART 4

CONTRACTOR FURNISHED ITEMS AND SERVICES

4. CONTRACTOR FURNISHED ITEMS AND RESPONSIBILITIES:

4.1. The contractor shall provide all reagents, testing systems, equipment, personnel, transportation, materials, supervision, maintenance of all equipment, training and other items and all other items necessary to perform Automated Microbiology and Antibiotic Susceptibility Testing as defined in the Performance Work Statement. Except for those items specified as government furnished property and services. The contractor shall perform to the standards in this contract.

4.2. Reagent Minimum Requirements: All reagent kits must be FDA approved and will exhibit at least a 90% agreement rate. Upon request, sufficient reagents and samples shall be provided by the contractor for in‐house evaluation of each reagent. Following evaluation, each test kits shall exhibit at least 90% agreement with test kits currently in use in the Microbiology Laboratory. The contractor will be the sole manufacturer and distributor of reagents. Testing Panels must have a long shelf life (>9 months). The contractor will provide assistance troubleshooting any issues that result from College of American Pathologist (CAP) proficiency tests. The contractor shall comply with all FDA regulations, the current CAP checklist, and Clinical Laboratory Standards Institute (CLSI) recommendations.

PART 5

APPLICABLE PUBLICATIONS

5. APPLICABLE PUBLICATIONS (CURRENT EDITIONS)

5.1. The Contractor must abide by all applicable regulations, publications, manuals, and local policies and procedures.

Publications Code:

AFI ‐ Air Force Instruction AMC ‐ Air Mobility Command DoDI ‐ DoD Instruction MDGI ‐ 60th Medical Group Instruction College of American Pathologists Joint Commission Food and Drug Administration

DEPARTMENT OF DEFENSE and AIR FORCE PUBLICATIONS:

Number Title of Directive

DFARS 252.237-7023 Continuation of Essential DOD Contractor Services

DoDM 5400.7 DoD Freedom of Information Act

Air Force Sup DoD Freedom of Information Act DoDI 5500.7‐R Joint Ethics Regulation (JER) DoDM 6025.18 Health Information Privacy Regulation AFI 33‐129 Transmission of Information Via the AMC Sup 1 Transmission of Information via the Internet

AFI 33‐201 Communications Security (COMSEC)

AFI 33‐332 Air Force Privacy Act Information

AMC Sup 1 Air Force Privacy Act Information

DHA‐IPM 18‐013 Interim Procedures 18‐013, Risk Management Framework

Travis Air Force Base Environmental Management Policy for Contractors available at https://www.travis.af.mil/Portals/30/Travis%20AFB%20Envir%20Policy.pdf

Privacy Act Systems of Records Notice(s) at https://dpcld.defense.gov/Privacy/SORNsIndex/DOD-Component-Notices/Air-Force-Article-List/ https://www.travis.af.mil/Portals/30/Travis%20AFB%20Envir%20Policy.pdf https://dpcld.defense.gov/Privacy/SORNsIndex/DOD-Component-Notices/Air-Force-Article-List/

PART 6

ATTACHMENT/TECHNICAL EXHIBIT LISTING

6. Attachment/Technical Exhibit List:

6.1. Attachment 1/Technical Exhibit 1 – Performance Requirements Summary

6.2. Attachment 2/Technical Exhibit 2 – Deliverables Schedule

6.3. Attachment 3/Technical Exhibit 3 – Estimated Workload Data

6.4. Attachment 4/Appendix A- General Equipment and Service Requirements

TECHNICAL EXHIBIT 1

PERFORMANCE REQUIREMENTS SUMMARY

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

SS#

Performance Objective

PWS

Section

Performance Threshold and Remedy

Surveillance Method

Rating

Technical/Quality of Product or Service 1 Analyzer meets characteristics of performance and accuracy defined by 1988 CLIA and

CLSI.

Part 1.3 & 4.2

95% • Monthly Surveillance

• Customer Complaint

Exceptional, Very Good, Satisfactory, Marginal, Unsatisfactory

2 Preventive maintenance and tech support meet requirements for availability and response

Part 1.6 &

One defect per performance period.

Correction can be accomplished with phone call or next visit on a one time basis

• Monthly Surveillance

• Customer Complaint

Exceptional, Very Good, Satisfactory, Marginal, Unsatisfactory

3 Maintain and utilize up to date CLSI susceptibility breakpoints.

Part 4.2 & Appendix A

100% • Monthly Surveillance

• Customer Complaint

Exceptional, Very Good, Satisfactory, Marginal, Unsatisfactory

4 Equipment must function with a 95% up-time and ability to perform patient testing

Part 1.3 100% • Monthly Surveillance

• Customer Complaint

Exceptional, Very Good, Satisfactory, Marginal, Unsatisfactory

Management or Business Relations 5 Responsiveness for customer inquiries and provides solution within 2 business days

Part 1.6.4 100% • Monthly Surveillance

• Customer Complaint

Exceptional, Very Good, Satisfactory, Marginal, Unsatisfactory

SURVEILLANCE OF NON -SERVICE SUMMARY ITEMS

Non-Service Summary Items

PWS

Para No.

Lab Supervisor Responsibilities

1. Completion and approval of the instrument installation and validation Section 1.6.14 Lab supervisor will review and ensure compliance with College of

American Pathologist

2. Initial inspection of contractor owned equipment Part 1.6.6 Lab Supervisor will schedule and coordinate with Biomedical

Equipment Maintenance Section prior to use in Medical Treatment Facility

TECHNICAL EXHIBIT 2

DELIVERABLES SCHEDULE

Deliverable Frequency # of Copies Medium/Format Submit To Equipment

Service/Repair Reports Within 24 hours of the performed service and/or equipment repair.

1 Copy will be submitted Copies will be digital and emailed to the designated point of contact.

Laboratory supervisor and Medical Equipment and Repair Department.

TECHNICAL EXHIBIT 3

ESTIMATED WORKLOAD DATA

DGMC ID by Mass Spectrometer (MS), Biochemical ID, and AST Estimated Workload

ITEM NAME ESTIMATED QUANTITY

1 Biochemical Identification 300 2 Antimicrobial Susceptibility Testing 3000 3 Mass Spectrometer Identification 6000

Appendix A

General Equipment/System Requirements:

• Instruments and assays are FDA cleared/approved (Vendor must provide proof of certification).

• No FDA warning letters issued over the past 24 months.

• Must have an automated microbiology platform capable of identification and susceptibility testing.

• Must be associated with a Matrix Assisted Desorption/Ionization Time of Flight (MALDI-TOF) Mass

Spectrometer.

• Must be capable of processing 50 panels per day. The contractor will provide enough instrumentation, reagent and consumables to complete approximately 6,000 panels per year.

• Must be able to complete ID panels in an average of 8 hours not to exceed 24 hours.

• Must be able to ID AND perform ASTs on minimal organism colonies from aerobic, throat, blood, stool, respiratory, and urine specimens/cultures

• Must have specialty identification panels for Yeast, Anaerobes, Haemophilus, and Neisseria.

• Must have the capability of reloading sample, reagent and supplies without interruption from sample processing

• Include the most current and up to date CLSI breakpoints on all susceptibility tests.

• No on-board reagents

• Instrumentation must have a closed system to avoid leakage and contamination.

• All equipment must be on the Approved Products List (APL) and must be able to obtain an interim

Authorization to Operate (ATO) within 30 days for networked or standalone information technology to receive, process, store, display, or transmit Defense Health Agency (DHA) information.

• Electrical Requirement: 120V

• Operating Temperature: 15°C ‐ 30°C

• Operating Humidity: Between 20°C‐90°C, relative, non‐condensing

• A printer with the capability of printing a patient report with patient demographic information that includes minimally the patient's name/accession number is required.

• An uninterruptible power supply (UPS) for each instrument provided under this contract must be provided by the vendor and included in the total package quote as a line item.

• The total equipment package, per specifications, to be installed will not negatively impact the functionality/operations of that laboratory, nor will it require significant and/or costly infrastructure changes, as deemed by laboratory management

Mass Spectrometer Instrumentation Minimum Requirements:

• Must be associated with a Matrix Assisted Desorption/Ionization Time of Flight (MALDI‐ TOF) Mass Spectrometer.

• Auto‐discrimination (reads more than one bar code symbology)

• Must have a robust FDA approved data base to include esoteric organisms without additional cost

(numerous aerobic gram pos/neg, anaerobic, fungal/yeast, haemophilus, mycobacterium).

• Must have a database with a large number of Research Use Only organisms that are being consistently submitted to the FDA for diagnostic clearance. Once organisms are cleared they will be available in the FDA approved data base at no additional charge.

Middleware Instrumentation Minimum Requirements:

• Must have auto‐verification capabilities.

• Must have a bidirectional laboratory information system that is compatible with Medical Health System

Genesis (Cerner Millennium) or the current LIS system of the DGMC laboratory.

• Must provide a seamless interface link between the Biochemical Identification Instrumentation, Antibiotic

Susceptibility Instrumentation, Blood Culture Instrumentation and MALDI‐TOF Mass Spectrometer Instrumentation.

• Operating systems will run on Windows 7 or newer (equivalent) and will be upgraded as necessary to ensure system is maintained in accordance with Air Force guidance. Will not install any system with Windows XP.

• Must provide middleware server for DGMC Laboratory.

Equipment/services with the following technical features:

• Contractor must assess equipment, work flow, workload volumes and space to meet the individual site requirements with minimum costs.

• Customizable reports (e.g. QC, Patient and Workload Reports, antibiograms)

• Audit trail capability (e.g. Operator ID, Panel Type, Date Placed on Instrument, etc.)

• All gram positive and gram negative identification results must not be held for greater than 24 hours from the time they are placed on the analyzer.

• All organism identification results must be objective without technician manipulation