NOI 36C25624Q0962 Sterrad.pdf

NOTICE OF INTENT TO AWARD SOLE SOURCE

I. The Department of Veterans Affairs, Network Contracting Office 16, Michael E. Debakey VA Medical Center (MEDVAMC) located at 5075 Westheimer Road, GFC Suite 750, Houston, TX 77056, hereby provides notice of its intent to award a sole-source, firm-fixed-price contract, for a base year and four 1-year options, to Advanced Sterilization Products (ASP), 33 Technology Drive, Irvine, CA, 92618. The contractor shall provide all hardware, firmware, installation, parts, labor and preventive maintenance on the STERRAD NX unit with ALLClear software located at Alexandria VA Medical Center, 2495 Shreveport Highway, Sterile Processing Department (SPD), Pineville, LA 71360.

II. The North American Industry Classification (NAICS) code for this acquisition is 811210

Electronic and Precision Equipment Repair and Maintenance (SBA Size Standard $34.0 Million).

III. This purchase will be made under Simplified Acquisition Procedures and Other than Full and Open Competition, as authorized by FAR 6.302-1 and in accordance with FAR 13.106- 1(b). The Government intends to award a Firm-Fixed-Price contract, in accordance with

FAR 16.202-1.

IV. The anticipated award date is June 11, 2024. The Government intends to award a Firm- Fixed-Price contract

V. Please note that this is not a request for competitive quotes and is being posted for informational purposes only. Interested contractors, in addition shall provide the following information as an attachment to your response:

1. Identify any other companies owned (wholly or in-part) by the owners of this business who provide goods or services under the same or a related NAICS codes.

2. Identify any other companies owned (wholly or in-part) by the owners of this business who provide goods or services that are registered under the same or a related NAICS code with the Center for Veterans Enterprise (CVE); Provide the certification type (SDVOSB/VOSB), Federal Identification Number, and state of incorporation for each.

3. Do you plan on responding to a solicitation for this requirement with a Joint Venture utilizing multiple owned companies as majority or non-majority owner?

Yes ___No ___ If yes, please identify which companies you are considering a Joint Venture and the ownership of each company.

4. Do you have an existing GSA or VA, Federal Supply Schedule contract, please include the contract details in your response.

VI. Interested parties shall identify their interests and capability to respond to this requirement within Ten (10) calendar days of the publication of this notice. Any response to this notice shall show clear and convincing evidence that competition would be advantageous to the Government.

Interested parties shall submit clear evidence with the capability to meet government requirement. To include but not limited to:

1. Capability to provide all hardware, firmware, installation, parts, labor and preventive maintenance on the STERRAD NX equipment at the Alexandria VA Medical Center, Sterile Processing Department, 2495 Shreveport Highway, Pineville, LA 71360. The Contractor shall furnish all labor, materials, parts, equipment, tools to service and perform yearly preventative maintenance on the STERRAD NX equipment.

See Attached Draft Performance Work Statement (PWS)

VII. Questions regarding this notice should be sent to Contracting Specialist Mari Gibson no later than 05/31/2024 by 10:00am (CST) at mari.gibson@va.gov

VIII. Responses to this notice should be sent to Contracting Specialist Mari Gibson no later than 06/04/2024 by 10:00am (CST) at mari.gibson@va.gov mailto:mari.gibson@va.gov mailto:mari.gibson@va.gov

PERFORMANCE WORK STATEMENT

FOR

STERRAD NX STERILIZER SERVICE AND REPAIR

Alexandria VA Health Care System

Sterile Processing Department (SPD)

2495 Shreveport Hwy 71

Pineville, Louisiana 71360

17MAY2024

TABLE OF CONTENTS

SECTION NUMBER AND TITLE PAGE(s)

1.0. SCOPE OF WORK …………………………………………………………………………………………….. 3

2.0. DELIVERABLES ………………...……………………………………………………………………………… 3 - 4

3.0. GENERAL INFORMATION ………………………………………………………………………………… 4 - 6

3.1 PERIOD OF PERFORMANCE ………………………………………………………………………………. 4

4.0. INFORMATION SECURITY….…………………………………………………………………………….. 6 - 7

5.0 QUALITY ASSURANCE SURVEILLANCE PLAN (QASP) …………………………………………. 7 - 8

5.4 ROLES AND RESPONSIBILITIES …………………………………………………………………………. 8 - 9

6.0 IDENTIFICATION OF REQUIRED PERFORMANCE STANDARDS/QUALITY LEVELS…….9

7.0. METHODOLOGIES TO MONITOR PERFORMANCE ……………………………………………… 9

8.0 CUSTOMER FEEDBACK ……………………………………………………………………………………… 9 - 10

9.0 QUALITY ASSURANCE DOCUMENTATION ………………………………………………………… 10

10. MONITORING FORMS ……………………………………………………………………………………… 10

11. ANALYSIS OF QUALITY ASSURANCE ASSESSMENT……………………………………………. 10 - 11

12. GOVERNMENT FURNISHED EQUIPMENT, SUPPLIES AND/OR SERVICES……………... 11

ATTACHMENT 1: PERFORMANCE REQUIREMENTS SUMMARY ………………………………

ATTACHMENT 2: QUALITY ASSURANCE MONITORING FORM…………………………………….13

1.0 SCOPE

This is a non-personal contract. Contractor shall provide all management, licensing, transportation, tools, supplies, equipment, parts, supervision, personnel, and labor necessary to provide support via telephone, planned maintenance including preventative maintenance, unscheduled, and emergency service as specified in section 2 for one - Sterrad NX unit with All Clear software, Serial number 4033215452.

2.0. Deliverables

2.1 Facility

Alexandria VA Medical Center, SPD, 2495 Shreveport Hwy 71, Pineville, LA 71360

2.2. Support via telephone.

2.2.1. Contractor shall issue the AVAMC a customer support telephone contact number for technical support.

2.2.2. The VA personnel will contact the contractor customer support center when service is necessary.

If contractor support personnel are not available to assist over the phone, the AVAMC shall expect a return call within 2 hours.

2.3. Scheduled Service

2.3.1. Preventative Maintenance (PM)

2.3.2. Contractor shall maintain an Inspection and preventative maintenance(PM) schedule for the

Sterrad NX All Clear unit, Serial number 4033215452 according to OEM specifications.

• PM includes Labor and Travel to perform the OEM's Periodic Manufacturer's Certification, electrical safety checks, and software updates for no additional charge.

• PM parts shall be included for no additional charge.

2.4. Unscheduled and Emergency Service

2.4.1 On-site Response Times

• Based on the priority of the service issue, the AVAMC shall expect contactor service personnel on site by the next business day or as mutually agreed. Equipment that is down is expected to be returned to service on the first call or by the next business day or as mutually agreed.

• All cost associated with travel, labor, and parts shall be included in the contract price.

2.5. Documentation

• Upon completion of service, the services performed will be documented on the work orders and provided by contractor Field Service technician to the Sterile Processing department.

3.0. GENERAL INFORMATION

3.1 Period of Performance

• The period of performance for this contract shall be for one Base period of 12 months and four

12-month option periods.

3.2. Hours of Operation.

• The daytime hours of operation are 0800 to 1630 Central Standard

Time (CST), Monday – Friday, excluding federal holidays.

• If the Contractor wishes to perform any services outside of the normal hours of operation, the

Contractor shall coordinate with the AVAMC Sterile Processing department.

3.3. Federal Holidays. The Contractor will not be required to work any of the following federal holidays:

New Year’s Day - 1 January

Martin Luther King Day - 3rd Monday in January

President's Day - 3rd Monday in February

Memorial Day - last Monday in May

Juneteenth - 19 June

Independence Day - 4 July

Labor Day - 1st Monday in September

Columbus Day - 2nd Monday in October

Veteran’s Day - 11 November

Thanksgiving Day - 4th Thursday in November

Christmas Day - 25 December

• If a holiday falls on Saturday, the preceding Friday shall be observed. If a holiday falls on

Sunday, the following Monday shall be observed. If a holiday falls on a scheduled service day, the Contractor shall be responsible for rescheduling services for the first day post the holiday observance.

3.4. English Language Requirement. All Contractor personnel shall read, understand, speak and write English fluently.

3.5. Communication. Contractor personnel shall maintain open and professional communication with government personnel at all times. Complaints validated by a AVAMC employee will be reported to the CO. Failure of the Contractor to take corrective action on validated complaints raised by the AVAMC, or the CO will be considered a failure to perform.

3.6. Appearance. Contractor personnel shall present a professional, conservative, and neat appearance. Contractor personnel shall report for duty in a professional manner, in appropriate attire and having complied with socially acceptable standards of personal hygiene.

3.7. Contractor Identification. All Contractor personnel attending meetings and working in other situations where their contractor status is not obvious are required to identify themselves as such to avoid being mistaken for Government officials. Contractors performing work at Government workplaces shall provide their employees with an easily readable identification (ID) badge indicating the employee's name, and the Contractor's name. Contractors shall require their employees to wear the ID badges visibly when performing work at Government workplaces. Contractor personnel must also ensure that all e-mails, documents, or reports they produce are suitably marked as Contractor products or that Contractor participation is appropriately disclosed. All signature blocks on e-mails shall indicate the Contractor's name.

3.8. 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 any Department of Veterans Affairs

Veterans’ Health Administration’s property.

4.0 INFORMATION SECURITY

4.1. BACKGROUND

In accordance with VA policy, contractors’ storage, generation, transmission or exchanging of VA sensitive information requires appropriate security controls to be in place. The VA Information Security Program policy – VA Directive and Handbook 6500 and additional 6500 series directives and handbooks - provide the framework for information security within VA.

4.1.1. The scope of this contract shall not include the acquisition of only commodities or goods (e.g.

equipment or software) except as necessary for repairs or OEM required software updates to the equipment within the scope of this contract where software updates or repairs do not allow for contractor to connect to the VA network.

4.1.2. This contract shall not involve VA Sensitive information.

4.1.3. This contract requires services of contractor personnel which will not perform a function that requires access to a VA system or VA sensitive information (e.g., system administrator privileged access to a VA system, or contractor systems or processes that utilize VA sensitive information).

4.1.4. This contract may require use of a contractor owned Information Technology (IT) system or computer assets located at an offsite location.

4.1.5. The contractor owned IT system shall not be connected to a VA network.

4.1.6. The contractor shall have exclusive administrative control of the contractor owned IT components.

4.1.7. The scope of this contract shall not include processing or storing VA Information.

4.1.8. This contract shall not include services that involve connection of contractor-owned IT devices (such as a laptop computer or remote connection from a contractor system) to a VA internal trusted (i.e., nonpublic) network.

4.1.9. The scope of this contract does not involve the storage, generating, transmitting, or exchanging of VA sensitive information.

5.0 QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

5.1 INTRODUCTION

This quality assurance surveillance plan (QASP) is pursuant to the requirements listed in the performance work statement(PWS) entitled STERRAD NX STERILIZER SERVICE AND REPAIR.

This plan sets forth the procedures and guidelines the AVAMC Biomedical office will use in ensuring the required performance standards or services levels are achieved by the contractor.

5.1.1. Purpose

5.1.1.2. The purpose of the QASP is to describe the systematic methods used to monitor performance and identify required documentation and resources to be employed.

The QASP provides a means for evaluating whether the contractor is meeting the performance standards/quality levels identified in the PWS.

5.1.1.3. This QASP defines the roles and responsibilities of all members of the project team, identifies the performance objectives, defines the methodologies used to monitor and evaluate the contractor’s performance, describes quality assurance documentation requirements, and describes the analysis of quality assurance monitoring results.

5.2. Performance Management Approach

5.2.1. The PWS structures the acquisition around what service or quality level is required, as opposed to how the contractor should perform the work (i.e., results, not compliance). This

QASP will define the performance management approach taken by the Sterile Processing department at the Alexandria VA Medical Center to monitor and manage the contractor’s performance to ensure the expected outcomes or performance objectives communicated in the PWS are achieved. Performance management rests on developing a capability to review and analyze information generated through performance assessment. The ability to make decisions based on the analysis of performance data is the cornerstone of performance management.

This analysis yields information that indicates whether expected outcomes for the project are being achieved by the contractor.

5.2.2. Performance management represents a significant shift from the more traditional quality assurance (QA) concepts in several ways. Performance management focuses on assessing whether outcomes are being achieved and to what extent. This approach migrates away from scrutiny of compliance with the processes and practices used to achieve the outcome.

A performance-based approach enables the contractor to play a large role in how the work is performed if the proposed processes are within the stated constraints. The only exceptions to process reviews are those required by law (federal, state, and local) and compelling business situations, such as safety and health. A “results” focus provides the contractor flexibility to continuously improve and innovate over the course of the contract if the critical outcomes expected are being achieved and/or the desired performance levels are being met.

5.3. Performance Management Strategy

5.3.1. The government representative(s) will monitor performance to determine how the contractor is performing against communicated performance objectives. The contractor will be responsible for making required changes in processes and practices to ensure performance is managed effectively.

5.4 ROLES AND RESPONSIBILITIES

5.4.1. The Contracting Officer (CO/KO)

The CO is responsible for monitoring contract compliance, contract administration, and cost control, and resolving any differences between observations documented by the

Sterile Processing department of the AVAMC and the contractor. The CO may designate one full-time COR as the government authority for performance management.

5.4.2 The COR

The COR, if delegated by the CO, is designated in writing by the CO to act as their authorized representative to assist in administering a contract. COR limitations are contained in the written appointment letter. The COR is responsible for technical administration of the project and ensures proper government surveillance of the contractor’s performance. The COR is not empowered to make any contractual commitments or authorize any contractual changes on the government’s behalf. Any changes the contractor deems may affect contract price, terms, or conditions must be referred to the CO for action. The COR will have the responsibility for completing QA monitoring forms used to document the inspection and evaluation of the contractor’s work performance. Government surveillance may occur under the inspection of services clause for any service relating to the contract.

6. IDENTIFICATION OF REQUIRED PERFORMANCE STANDARDS/QUALITY LEVELS

The required performance standards and/or quality levels are included in Attachment 1, Performance

Requirements Summary.

7. METHODOLOGIES TO MONITOR PERFORMANCE

7.1 Surveillance Techniques

To minimize the performance management burden, simplified surveillance methods shall be used by the government to evaluate contractor performance when appropriate. The primary method of surveillance will include periodic monitoring, which shall be performed by the COR or other government employee.

8. Customer Feedback

8.1. The contractor is expected to establish and maintain professional communication between its employees and customers. The primary objective of this communication is customer satisfaction. Customer satisfaction is the most significant external indicator of the success and effectiveness of all services provided and can be measured through customer complaints.

8.2. Performance management drives the contractor to be customer focused through initially and internally addressing customer complaints and investigating the issues and/or problems, but the customer always has the option to communicate complaints to the CO or the Sterile Processing department as opposed to the contractor.

8.3. Customer complaints, to be considered valid, must set forth clearly and in writing the detailed nature of the complaint, must be signed, and must be forwarded to the Sterile

Processing department. The Sterile Processing department will accept those customer complaints and investigate.

8.4. Acceptable Quality Levels

8.4.1. The acceptable quality levels (AQLs) included in Attachment 1 for contractor performance is structured to allow the contractor to manage how the work is performed. For certain critical activities, such as emergency service calls, the desired performance level is established at 95 percent. Other levels of performance are keyed to the relative importance of the task to the overall mission performance at

Alexandria VA Health Care System.

9.0 Quality Assurance Documentation

9.1. The Performance Management Feedback Loop

The performance management feedback loop begins with the communication of expected outcomes. Performance standards are expressed in the PWS and assessed using the performance monitoring techniques shown in Attachment 1.

10. Monitoring Forms

10.1. The government’s QA surveillance, accomplished by the Sterile Processing department will be reported using the monitoring form in Attachment 2. The forms, when completed, will document the government’s assessment of the contractor’s performance under the contract to ensure the required results.

10.1.2 The Sterile Processing department will retain a copy of all completed QA surveillance forms.

11. ANALYSIS OF QUALITY ASSURANCE ASSESSMENT

11.1. Reporting

11.1.1 At the end of each contract year the Sterile Processing department will prepare a written report summarizing the overall results of the quality assurance surveillance of the contractor’s performance. This report and the completed quality assurance monitoring forms

(Attachment 2), will become part of the QA documentation. It will enable the government to demonstrate whether the contractor is meeting the stated objectives and/or performance standards, including cost/technical/scheduling objectives.

11.2. Reviews and Resolution

11.2.1. The Sterile Processing department may require the contractor’s project manager or designated alternate to meet with the Sterile Processing department and other government personnel as deemed necessary to discuss the performance evaluation. If the need arises, the contractor will meet with the

Sterile Processing department as often as required or per the contractor’s request. The agenda of the reviews may include:

• Monthly performance assessment data and trend analysis

• Issues and concerns of both parties

• Projected outlook for upcoming months and progress against expected trends, including a corrective action plan analysis

• Recommendations for improved efficiency and/or effectiveness

• Issues arising from the performance monitoring processes

11.2.2. The Sterile Processing department must coordinate and communicate with the contractor to resolve issues and concerns regarding marginal or unacceptable performance.

11.2.3. The Sterile Processing department and contractor should jointly formulate tactical and long-term courses of action. Decisions regarding changes to metrics, thresholds, or service levels should be clearly documented. Changes to service levels, procedures, and metrics will be incorporated as a contract modification at the convenience of the procuring CO.

12.0. GOVERNMENT FURNISHED EQUIPMENT, SUPPLIES AND/OR SERVICES.

12.1. Contractor Furnished Items and Services.

Except for those items or services specifically stated in this PWS to be government-furnished, the

Contractor shall furnish everything required to perform this contract in accordance with all of its terms and conditions. It is the Contractor’s responsibility to ensure 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.

12.2. Utilities. The Government will provide the utilities necessary for the Contractor to perform services in accordance with the terms and conditions of the contract.

ATTACHMENT 1: PERFORMANCE REQUIREMENTS SUMMARY

Required Services (Tasks) Performance Threshold

Method of Surveillance

Contractor is to complete PM service according to OEM specifications.

Section 2.2.2.

100% Periodic Inspection and customer complaints.

Services performed will be documented on the work orders and provided by contractor Field Service technician.

Section 2.4.

95% Periodic Inspection and customer complaints.

Based on the priority of the service issue, the AVAMC shall expect contactor service personnel on site by the next business day or as mutually agreed.

Section 2.3.1.

95% Periodic Inspection and customer complaints.

Upon the VA personnel contacting the contractor customer support center for a service request, the AVAMC shall expect a return phone call from a field technician within two hours.

Section 2.1.2.

95% Periodic Inspection and customer complaints.

ATTACHMENT 2: QUALITY ASSURANCE MONITORING FORM

SERVICE or STANDARD:

SURVEY PERIOD:

SURVEILLANCE METHOD (check):

Random Sampling 100% Inspection Periodic Inspection Customer Complaint

LEVEL OF SURVEILLANCE (check):

Monthly Quarterly As needed

PERCENTAGE OF ITEMS SAMPLED DURING SURVEY PERIOD: ______ %

ANALYSIS OF RESULTS:

Observed Service Provider Performance Measurement Rate: ______%

Service Provider’s Performance (check): Meets Standards

Does Not Meet Standards

Narrative of Performance During Survey Period:

PREPARED BY: ___________________________________ DATE: _________________