PWS_Draft.docx

PERFORMANCE OF WORK STATEMENT (PWS)

Karl Storz Endoscope Maintenance Agreement Healthcare technology Management Services

Part 1

General Information

1. GENERAL: This is a non-personnel services contract to provide Protection 1 Risk-Share Comprehensive Service Agreement for the exchange and repair needs of the Karl Storz branded products listed under equipment list for Brooke Army Medical Center, Ft. Sam Houston, TX. 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 personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to perform the OEM sponsored modifications, they will have knowledge of, furnish and install all OEM equipment at no additional charge, as defined in this 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: This is a contract renewal requirement for BAMC. An endoscope is an illuminated optical instrument that is used to look deep inside the body to examine internal organs, such as the throat or esophagus. Surgical providers at BAMC utilize a variety of endoscopes from several manufacturers in order to visually examine, diagnose, and assist in different surgical procedures.

1.3 Objectives:

(a) Contingent upon Customer trading in its rigid scope products for the exchange of KARL STORZ Rigid Scope Products listed on Exhibit A, KARL STORZ shall provide Customer a price reduction for servicing the Products listed on Exhibit A. All Customer’s trade-in products submitted for exchange shall become the property of KARL STORZ.

(b) Exchange out any damaged Products listed on Exhibit A, as necessary, to ensure such Products are in normal operating condition, provided that such service is necessitated by (i) the failure of or (ii) accidental damage to the Product during normal usage for its intended purpose and such failure is not otherwise excluded from coverage. The number of exchanges that may be performed on the Products listed on Exhibit A is unlimited.

(c) Provide technology updates, as designated by KARL STORZ, at the time of exchange or repair.

(d) Upon request, provide a Damage Evaluation Report for each Product repaired or exchanged.

(e) Pay shipping costs to and from Customer using KARL STORZ’s preferred carrier.

1.4 Scope: Karl Storz shall keep the system in good operating condition, meeting all published equipment requirements and standard specification listed by the OEM. In some cases including but not limited to: cleaning the system, checking the mechanical reliability and positioning accuracy, checking for potential problem components, performing a complete alignment that includes all the system potentiometers, and verification of electronic and hardware performance.

1.5 Period of Performance: The period of performance shall be for one (1) Base Year of 12 months and two (2) 12-month option years. The Period of Performance reads as follows:

Base Year - 1 Sep 2024 – 31 Aug 2025 Option Year I - 1 Sep 2025 – 31 Aug 2026 Option Year II - 1 Sep 2026 – 31 Aug 2027

1.6 General Information

1.6.1 Quality Control: The contractor shall develop and maintain an effective quality control program to ensure services are performed in accordance with this PWS. The contractor shall develop and implement procedures to identify, prevent, and ensure non-recurrence of defective services. The contractor’s Quality Control Program (QCP) is the means by which he assures himself that his work complies with the requirement of the contract. The QCP is to be delivered, within 30 days after contract award three copies of a comprehensive written QCP shall be submitted to the KO and COR within 5 working days when changes are made thereafter. After acceptance of the quality control plan the contractor shall receive the contracting officer’s acceptance in writing of any proposed change to his QC system.

1.6.2 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).

1.6.3 Recognized Holidays: Contractor is NOT required to perform services on these recognized Federal Holidays.

Independence Day

1.6.4 Hours of Operation: The contractor is responsible for conducting business, between the hours of 0700 – 1600 hrs (7 a.m. – 4 p.m.) 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.

1.6.5 Place of Performance: The work to be performed under this contract will be performed at Brooke Army Medical Center (BAMC), Healthcare Technology Management Services (HTMS), 3551 Roger Brooke Drive, Ft. Sam Houston, TX 78234.

1.6.6 Type of Contract: The government will award a Fixed Firm Priced Contract.

1.6.7 Security Requirements: The representative must have either an access base pass or a DBIBS ID card submitted by the COR or ACOR and approved by 502nd Security Forces Squadron, Fort Sam Houston, TX to gain access to BAMC. Upon arrival at BAMC the representative will contact COR or ACOR to be escorted to Biomedical Engineering to sign the visitors log and then be escorted to the equipment location.

1.6.8 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, Contracting Officers Representative (COR), 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.

1.6.10 Contracting Officer Representative (COR): The (COR) will be identified by separate letter. The COR monitors all technical aspects of the contract and assists in contract administration The COR is authorized to perform the following functions: assure that the Contractor performs the technical requirements of the contract:

perform inspections necessary in connection with contract performance: maintain written and oral communications with the Contractor concerning technical aspects of the contract: issue written interpretations of technical requirements, including Government drawings, designs, specifications: monitor Contractor's performance and notifies both the Contracting Officer and Contractor of any deficiencies; coordinate availability of government furnished property, and provide site entry of Contractor personnel. A letter of designation issued to the COR, a copy of which is sent to the Contractor, states the responsibilities and limitations of the COR, especially with regard to changes in cost or price, estimates or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting order.

1.6.11 Key Personnel: The follow personnel are considered key personnel by the government: Gerd Schwalbe, Primary COR, 210-539-9843; Art. Navarrette, Secondary COR, 210-916-8966.

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, 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. CONTRACTING OFFICER'S REPRESENTATIVE (COR). An employee of the U.S. Government appointed by the contracting officer to administer the contract. Such appointment shall be in writing and shall state the scope of authority and limitations. This individual has authority to provide technical direction to the Contractor as long as that direction is within the scope of the contract, does not constitute a change, and has no funding implications. This individual does NOT have authority to change the terms and conditions of the contract.

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

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

2.1.6. 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.

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

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

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

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

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

2.1.12. WORKDAY. 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:

ACOR Alternate Contracting Officer's Representative AFARS Army Federal Acquisition Regulation Supplement AR Army Regulation CCE Contracting Center of Excellence CFR Code of Federal Regulations CONUS Continental United States (excludes Alaska and Hawaii) COR Contracting Officer Representative COTR Contracting Officer's Technical Representative COTS Commercial-Off-the-Shelf DA Department of the Army DD250 Department of Defense Form 250 (Receiving Report) DD254 Department of Defense Contract Security Requirement List DFARS Defense Federal Acquisition Regulation Supplement DMDC Defense Manpower Data Center DOD Department of Defense FAR Federal Acquisition Regulation HIPAA Health Insurance Portability and Accountability Act of 1996 KO Contracting Officer OCI Organizational Conflict of Interest OCONUS Outside Continental United States (includes Alaska and Hawaii) ODC Other Direct Costs PIPO Phase In/Phase Out POC Point of Contact PRS Performance Requirements Summary PWS Performance Work Statement QA Quality Assurance QAP Quality Assurance Program QASP Quality Assurance Surveillance Plan QC Quality Control QCP Quality Control Program TE Technical Exhibit

PART 3

GOVERNMENT FURNISHED PROPERTY, EQUIPMENT, AND SERVICES

3. GOVERNMENT FURNISHED ITEMS AND SERVICES:

3.1. Services: The Government will:

a. Utilize KARL STORZ as its provider of the services for the Products listed on Exhibit A.

b. Submit all Products to KARL STORZ in a high-level disinfected or sterilized condition.

c. Obtain a Return Material Authorization (RMA) number from KARL STORZ prior to submitting any Products to KARL STORZ for exchange or repair.

d. Submit all damaged Products to be exchanged to KARL STORZ within ten (10) business days after issuance of a RMA number. If the damaged Product is not returned within thirty (30) days of receipt of the replacement Product, Customer will be invoiced for the list price of the replacement less any applicable discounts.

3.2 Facilities: N/A

3.3 Utilities: N/A

PART 4

CONTRACTOR FURNISHED ITEMS AND SERVICES

4. CONTRACTOR FURNISHED ITEMS AND RESPONSIBILITIES:

4.1 General: The Contractor shall furnish all supplies, equipment, facilities and services required to perform work under this contract that are not listed under Section 3 of this PWS.

Provide labor and replacement parts, as necessary, to return the Products listed on Exhibit A to normal operating condition, provided that such service is necessitated by device failure during normal usage for its intended purpose and such failure is not otherwise excluded from coverage. The number of repairs or exchanges that may be performed on the Products Subject to this Agreement is unlimited. All replaced parts shall become the property of Karl Storz.

a) Provide Field Service Technician visits where coverage is available*.

b) Provide technology updates, as designated by KARL STORZ, at the time of exchange or repair.

c) Upon request, provide a Damage Evaluation Report for each Product repaired or exchanged.

d) Pay shipping costs to and from BAMC using KARL STORZ’s preferred carrier.

Exclusions: The following items are excluded from coverage under this Agreement: cosmetic damage; Products that have been altered other than by KARL STORZ; consumable or disposable supplies (light bulbs, lamps, tubing, fuses, filters, electrodes, batteries, print packs, etc.); damage resulting from BAMC’s failure to follow manufacturers recommendations for care and handling; and damage arising or resulting from BAMC’s use in combination with adaptors, accessories and/or equipment from other manufacturers unless authorized or recommended KARL STORZ Product specific literature, instruction manual and/or labeling.

PART 5

SPECIFIC TASKS

5. Specific Tasks:

5.1. The contractor shall provide a comprehensive service agreement that fully covers repair services for Karl Storz endoscopes, offering unlimited repairs and exchanges for the life of the agreement.

The Comprehensive agreement includes:

a) Repair and exchanges for covered Karl Storz endoscopes.

b) Priority exchange and repair turn-around time.

c) Endoscopes that are newly manufactures and certified to meet all of the same high standards of quality, integrity and optical performance specifications as our new endoscopes.

d) Pre-paid shipping from and to Karl Storz facilities.

5.2 BAMC HTMS will when requesting replacement scope from Karl Storz provide the customer support representative with the following:

Once replacement endoscope is received from Karl Storz the HTMS tech will conduct a technical inspection to confirm that there is no issue with replaced endoscopes.

HTMS tech will then pack and return broken endoscope to Karl Storz with provided shipping label with RMA #.

PART 6

APPLICABLE PUBLICATIONS

6. APPLICABLE PUBLICATIONS (CURRENT EDITIONS)

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

PART 7

ATTACHMENT/TECHNICAL EXHIBIT LISTING

7. Attachment/Technical Exhibit List:

7.1 Technical Exhibit 1 – Performance Requirements Summary

7.2 Technical Exhibit 2 – Deliverables Schedule

TECHNICAL EXHIBIT 1

Performance Requirements Summary (PRS)

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.

PRS # 1.

The contractor shall provide a comprehensive service agreement that fully covers repair services for Karl Storz endoscopes, offering unlimited repairs and exchanges for the life of the agreement.

TECHNICAL EXHIBIT 2

DELIVERABLES SCHEDULE

All replacements shall be completed in a minimum amount of time not to exceed five (5) working days Replacement scope shall be provided to the COR within five

(5) working days from the date called in.

One field service report per serial number Hand Delivered/ Electronically/Email

COR