36C25719Q1080-001.docx

Sources Sought Notice: 36C25719Q1080

Draft Statement of Work

Background The VHA Directive 1116(2), “Sterile Processing Service (SPS)” states SPS must have a systematic plan to assess and retire malfunctioning instrumentation by utilizing a company or intra-facility service that is certified to refurbish instrumentation. Currently there is no service located within the facility that has the knowledge and training to inspect, sharpen and perform all steps in the refurbishing process. SPS does not have a contract with any refurbishing company at this time. The future goal is to acquire a service contract to be in compliance with the VHA Directive 1116(2). The goal and vision for the future is to receive recommendations for surgical instrument replacements, maintenance data, and quality assurance monitoring which will provide SPS with essential information to develop an annual budget for replacement instruments.

VISN 17 Instrument Sharpening and Repair deployment The Instrument Sharpening and Repair contract will service the following sites:

2 OBJECTIVES

The purpose of this project is to obtain a contract with a company that provides on-site refurbishing of critical and semi-critical reusable medical equipment and if necessary, off-site repairs for instruments that require extensive repairs. By obtaining a service of this type, instruments will be inspected, repaired, sharpened, lubricated, and marked unrepairable during scheduled visits. In doing so, instrumentation used by Veteran Affairs Medical Center/Health Care Service (VAMC/HCS) providers will be maintained in good working condition to enhance positive patient outcomes during ambulatory and surgical procedures. Furthermore, the Audie L. Murphy (ALM), Kerrville and DataPoint Sterile Processing Services (SPS) will be able to be compliant with the VHA Directive 1116(2).

The contractor shall perform services on-site at the respective VAMC. Instruments will be retrieved by the contractor and returned by the contractor on the same day. In the event that an instrument has extensive damage and cannot be repaired on-site, the contracting officer or designee must approve off-site repairs which may require a second level approval from a clinical manager or supervisor. If approved, the contractor will provide within 3 business days a description of the defect, repair options, cost, and estimated time repair will be completed.

Contracting officer or designee will determine whether to pursue off-site repair option or return instrument without repair. All instruments will be returned to the respective VAMC via the warehouse. Under no circumstance will the contractor retain VA property.

3 Scope of Work The contractor shall perform onsite service which will include the following:

· Inspection and repair of rigid containers and cassettes

· Inspection, sharpening, and repair of various stainless-steel instruments, power equipment repair, light cables, fiberoptic retractors, phaco handpieces, and laparoscopic instruments

· Replace damaged instrument parts with new, medical grade parts

· Electrosurgical instrument re-insulation

· Removal of instrument indicator tape

The contractor shall coordinate the arrival time for maintenance and repairs with the contracting officer representative or designee. The workload for respective facilities:

Audie L. Murphy: 8 – 10 Trays with approximately 36 visits per year Datapoint Dental: 410 – 430 Instruments with approximately 31 visits per year Kerrville: 410 – 430 Instruments with approximately 6 visits per year Upon completion of services, VAMC facilities will receive daily, weekly or monthly documentation of non-repairable instruments detailing the model number, manufacturer, description, reason deemed beyond useful life, and set identification so it can quickly be determined which set is incomplete. The frequency of reporting will be determined by each facility. The company must have a way of reporting these occurrences to the customers and tracks/trends the total amount of beyond repairs, the company must use a device tagged beyond repair, the reason why the device was deemed beyond repair and a digital image for the facilities review.

Each tray serviced must have a detailed repair history of the instruments repaired within each VAMC set. The company must have full reporting capabilities that can be exported 24/7 for the facility which include but are not limited to repair history by facility, department, equipment type, serial number, etc.

The company must provide the facilities with real-time, up-to-date records of all work orders and repairs upon request.

Each VAMC facility must also receive a report detailing the services provided. The report will include:

· Before and after pictures of instruments on select repairs

· Number of trays serviced – broken down by specialty

· Number of instruments inspected

· Number of instruments repaired

1. the software licenses This contract will not require services that involve connection of one or more contractor-owned IT devices (such as a laptop computer or remote connection from a contractor system) to a VA internal trusted (i.e., non-public) network. Subsequently, the C&A requirements do not apply, and a Security Accreditation Package is not required.

QUALIFICATIONS

To be determined responsible, a prospective contractor must be:

1. ISO 9001: 2015 Certified

2. International Association of Healthcare Central Service Materiel Management IAHCSMM Certified General Requirements The Contractor will coordinate with the Contracting Officer’s Representative (COR) for the contract regarding the dates of on-site visits, and otherwise work with the COR to ensure compliance with the terms and conditions of the contract.

PERIOD of PERFORMANCE Will be one-year base with four 1-year option renewals Record keeping/monitoring procedures The COR will be responsible for ensuring that services are provided in accordance with the terms and conditions of the contract.

security requirements

0.1 Information System Officer, Information Protection: The contractor will not have access to VA Desktop computers they will not have access to online resources belonging to the government.

0.2 Privacy Officer: The Contractor will not have access to protected Patient Health Information (PHI) nor will they have capability of accessing patient information during the services provided to the VA and if removal of equipment from the VA is required, any memory storage device will remain in VA control and will not be removed from VA custody. All research data available for Contractor analysis is de-identified.

0.3 Records Manager:

a. Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228.

b. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

c. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records.

d. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act.

e. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.

f. The Government Agency owns the rights to all data/records produced as part of this contract.

g. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

h. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].

i. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.

j. Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.

0.4 Physical Security

a) An ID badge will be issued by the VA Police which must be presented by all contractors at the VA entrance security check points. The issued badge is designated for official pick-up and deliveries of surgical instruments and trays.

b) ID badge must be worn at all times above the waist, in front, with the face of the card visible.

c) It is the responsibility of the contracting officer representative or designee to verify that the vendor has a temporary identification badge. If not, they are to be escorted to the VA Police and Security office. Once issued a temporary identification badge, the contractor will be escorted by the contracting officer representative or designee to SPS.

d) Contractor’s mobile unit/van shall be properly label with the company logo and registered with the VA Police Department and park in designated areas for service.

e) Upon arrival to the Sterile Processing Service, the contractor will be required to contact contract officer representative (COR) and/or shift supervisor.