RFQ 36C24823Q1958 Attachment B- PWS.pdf

36C24823Q1958

B.2 Statement of Work Laboratory Equipment Calibration and Certification Services at VACHS

I. OBJECTIVE:

A. The Veterans Affairs Caribbean Healthcare System (VACHS) utilizes freezers and refrigerators for laboratory processes. This type of equipment requires an annual calibration record as per The Joint Commission and other regulatory agencies. The purpose of this requirement is to establish a service contract to calibrate and certificate all instruments pertaining to freezers and refrigerators used in VACHS San Juan facility and outpatient clinics in Mayaguez (MOPC) and Ponce (POPC).

II. PERIOD OF PERFORMANCE:

The period of performance for this service contract is one (1) base year from the date of award, plus four (4) additional option years.

III. ACRONYMS:

This section lists acronyms that are used in this Statement of Work and other parts of the solicitation.

AABB – American Association of Blood Bank CLIA – Clinical Laboratory Improvement Amendments NIST – National Institute of Standards and Technology COR – Contracting Officer Representative FDA – U.S. Food & Drug Administration NFPA – National Fire Protection Association OSHA – Occupational Safety and Health Administration TJC – The Joint Commission

IV. REQUIRED SERVICES:

Contactor shall perform on-site calibrations and provide certifications on a yearly basis for all instruments shown on table below.

Description Manufacturer Model / Serial VA Number Location # Instruments

Ultra Low freezer (New)

Fisher Scientific 957RAKCO 65254519 Chemistry Qty. 2 (1 temperature sensor and 1 chart recorder)

Refrigerator Fisher Scientific R404A / 410N007

65181931 Chemistry Qty. 2 (1 temperature sensor and 1 chart recorder)

Refrigerator Fisher Scientific Isotemp Plus 65177449 Chemistry Qty. 2 (1 temperature sensor and 1 chart recorder)

Refrigerator Fisher Scientific R404A / 410N009

65181934 Chemistry Qty. 2 (1 temperature sensor and 1 chart recorder)

Refrigerator Fisher Scientific R404A / 410N0010

65181932 Chemistry Qty. 2 (1 temperature sensor and 1 chart recorder)

Refrigerator Fisher Scientific R404A / 410N002

65181935 Chemistry Qty. 2 (1 temperature sensor and 1 chart recorder)

Refrigerator Sanyo Electric SRL6110W / 050400049

65185953 Chemistry Qty, 1 temperature sensor

Refrigerator (samples)

Thermo Electric 7504A19 65194163 Chemistry Qty, 1 temperature sensor

Refrigerator & Freezer (send out)

Sanyo Electric MDR414F / 50202433

65185592 Chemistry Qty, 1 temperature sensor

Low Freezer Fisher Scientific TSX2330LA 65260293 Chemistry Qty. 2 (temperature sensor and 1 chart recorder)

Refrigerator Fisher Scientific R404A / 410N008

65181933 Hematology Coag.

Qty. 2 (1 temperature sensor and 1 chart recorder)

Refrigerator Sanyo Electric SRL6110W / 050400053

65185954 Hematology (samples)

Qty, 1 temperature sensor

Refrigerator Fisher Scientific 13986132 AR 65194448 Special Hematology

Qty. 2 (1 temperature sensor and 1 chart recorder)

Refrigerator Fisher Scientific W/RA / 13-986-

126RA

65204692 Point of Care Qty. 2 (1 temperature sensor and 1 chart recorder)

Refrigerator Thermo Electric LR423A20 65185951 Microbiology - Serology

Qty, 1 temperature sensor

Ultra-Low Thermo 906 65185289 Microbiology Qty. 2 (1 temperature

Freezer (Old) sensor and 1 chart recorder)

Ultra-Low Freezer (new)

Fisher Scientific 957RAKCO 65254518 Microbiology Qty, 1 temperature sensor

Refrigerator & Freezer

Sanyo Electric MDR414F / 50202435

65185593 Microbiology Qty, 1 temperature sensor

Cobas 6800 Freezer

Fisher Scientific TSG25FS SA / 300466384

65259966 Microbiology Qty. 2 (1 temperature sensor and 1 chart recorder)

Cobas 6800 Refrigerator

Fisher Scientific SG49RPSA / 300439773

65259968 Microbiology Qty. 2 (1 temperature sensor and 1 chart recorder)

Walking Refrigerator

KPS Global Modularm

75L/FT1142301

65267851 Microbiology Qt. 2 (1 temperature sensor and 1 chart recorder)

Blood Refrigerator 1

Jewett Refrigerator

BBR25-1B 65183670 Blood Bank Qty. 2 (1 temperature sensor and 1 chart recorder)

Blood Refrigerator 2

Jewett Refrigerator

620 65183669 Blood Bank Qty. 2 (1 temperature sensor and 1 chart recorder)

Blood Refrigerator

(OR)

Mallinckrodt / Forma Scientific

3644 / 18026-

23152 Blood Bank Qty. 2 (1 temperature sensor and 1 chart recorder)

Plasma Freezer Datum BPL325-2B 65183987 Blood Bank Qty. 2 (1 temperature sensor and 1 chart recorder)

Platelets Incubator PC900i

Helmer Laboratories Inc

PC900I /

1012236

65221288 Blood Bank Qty. 2 (1 temperature sensor and 1 chart recorder)

Reagents (Send Out Room)

Fisher Scientific TSX1205 GY 65261551 Blood Bank Qty, 1 temperature sensor

Refrigerator Sanyo Electric SRL6110W / 65185955 Receiving Qty, 1 temperature

050400283 sensor

Refrigerator Sanyo Electric SRL6111W / 070100239

65192628 Pathology – Cytology / Histology

Qty, 1 temperature sensor

Refrigerator Sanyo Electric SRJ6111W / 110801038

65212237 Pathology – Cytology / Histology

Qty, 1 temperature sensor

MOPC

Trautsen (Hem / Coag)

Hobart G21010 65215024 MOPC Laboratory

Qty, 1 temperature sensor

MOPC Chem Fisher Scientific TSX5005 PA 65264319 MOPC Laboratory

Qty, 1 temperature sensor

POPC So Low Environmental Equip

U85-18 / 2021500

65253608 POPC

Laboratory

Qty, 1 temperature sensor

POPC Fisher Scientific TSX5005 PA 65259988 POPC Laboratory

Qty, 1 temperature sensor

Thermometer Thermo Co 34291 Main Laboratory

Qty. 1

Thermometer H-B Instrument 164900 Main Laboratory

Qty. 1

Thermometer Thermo Co 6029 Main Laboratory

Qty. 1

Thermometer Thermo Co 6164 Main Laboratory

Qty. 1

Thermometer Thermo Co 34456 Main Laboratory

Qty. 1

Additions/Deletions: Additional instruments may be included, and/or current equipment may be deleted from the contract throughout the life of the contract via supplemental agreement.

V. REQUIREMENTS:

A. The contractor shall furnish all necessary equipment, materials, and labor to adequately perform the specified services in this scope.

B. On-site services for instruments calibration and certification shall be performed by a NIST accredited and registered laboratory complying with ISO 17025, ISO 10012, ANSI Z540 regulations and NIST standards with five (5) years of experience in this field as a minimum.

C. The contractor shall have comprehensive knowledge and experience of all the pertinent standards, laws, regulations, specifications, and procedures included in the following:

ANSI Z540, ISO 17025, ISO 10012, NIST – Standard Reference Material (SRM) and Standard Reference Instruments (SRI), and OSHA General Industry Standard.

D. Contractor technicians shall possess a graduate certificate on instrumentation or electronics and a minimum of 5 years’ experience in instrument calibration.

E. Contractor shall provide instruments certificates within 5 working days of performed calibration. The certificate shall include all instruments information along with calibration parameters, ranges, readings, calibration date, calibration expiration date, procedure used, equipment used, equipment used calibration expiration date and technician name.

F. Contractor shall provide and install calibration label to all instruments. Calibration label shall have the equipment VA number, calibration date and next due date.

G. Contractor shall include transportation expenses, shipping and handling of materials and tools required to fulfill the requirements of this contract.

H. Safety Requirements:

a. The contractor shall assure that its employees have received any necessary safety training on equipment to be used as part of this contract, any required Personal Protective Equipment (PPE), medical surveillance programs, individual health protection measures, and manufacturer's product and Safety Data Sheet (SDS), as required by OSHA. Contractor shall also comply with all applicable national safety codes and standards.

b. The contractor shall always maintain a copy of all current safety certifications at the site, as well as comply with all other site documentation requirements of applicable OSHA programs and this specification.

c. The Contractor will provide all labor, associated materials, personnel protective equipment, and all necessary equipment required for the services included in this contract. If the Contractor damages accidentally and/or intentionally any equipment or material, they shall repair it within 24 hours. Exceptions could be made if approved by the Contracting Officer (CO).

I. Scheduling:

a. Work shall be coordinated in advance to avoid services logistic issues.

b. Instruments on-site calibrations/certifications shall be coordinated with COR or designee 2-weeks in advance.

c. Instruments calibrations not necessarily will happen all at the same time, day or week. Therefore, Contractor may have to schedule calibration visits at different times.

J. Submittals:

a. Contractor shall submit the following certifications for company/laboratory:

• NIST accreditation- Certifications/accreditation shall be provided upon submittal of offer/quote.

b. Contractor shall submit the calibration certifications for all equipment to be used for our instrument’s calibrations.

VI. PERFORMANCE REQUIREMENT SUMMARY (PRS):

Performance

Objective (Task)

Performance

Standard

Monitoring

Method

Acceptable Quality Level (AQL)

Incentive (Positive / Negative)

Perform instruments calibrations according to standards

PWS Work Plan Periodic surveillance

Inspections.

All instruments shall be verified and certified with 100% accuracy

Immediate corrective action taken at no additional cost to the Government

Coordinate inspection, evaluation, and certification with

COR

prior to work performance

PWS

Email/Phone call validated through

CO/COR

95% of all inspections, evaluations, and certifications

Immediate corrective action taken at no additional cost to the Government

Provide certifications with all the information requested

PWS Report receipt validated through

CO/COR

100% of all inspections, and certifications

Immediate corrective action taken at no additional cost to the Government

VII. POINT OF CONTACT:

A. For coordination of services the contractor shall contact Eng. Orlando Bonilla-Méndez, O&M Engineer at: 787-641-7582 x-110425, email orlandob.bonillamendez@va.gov or designated Point of Contact.

VIII. VA INFORMATION CUSTODIAL LANGUAGE:

A. Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

B. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.

C. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

D. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

IX. SECURITY INCIDENT INVESTIGATION:

A. The term “security incident” means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the COR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access.

B. To the extent known by the contractor/subcontractor, the contractor/subcontractor’s notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant.

C. With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement.

mailto:orlandob.bonillamendez@va.gov

D. In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident.

X. LIQUIDATED DAMAGES FOR DATA BREACH:

A. Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract.

B. The contractor/subcontractor shall provide notice to VA of a “security incident” as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination.

XI. SECURITY CONTROLS COMPLIANCE TESTING:

A. On a periodic basis, VA, including the Office of Inspector General, reserves the right to evaluate any or all of the security controls and privacy practices implemented by the contractor under the clauses contained within the contract. With 10 working-days’ notice, at the request of the government, the contractor must fully cooperate and assist in a government-sponsored security controls assessment at each location wherein VA information is processed or stored, or information systems are developed, operated, maintained, or used on behalf of VA, including those initiated by the Office of Inspector General. The government may conduct a security control assessment on shorter notice (to include unannounced assessments) as determined by VA in the event of a security incident or at any other time.