PWS Draft.docx

PERFORMANCE WORK STATEMENT (PWS)

INSTRUMENT STERILIZATION

Sterile Processing Department (SPD)

PART 1

GENERAL INFORMATION

1. DESCRIPTION OF SERVICES. Sterile processing services for William Beaumont Army Medical Center (WBAMC) in support of patient care. Service is for hand washing and mechanical washing (to include ultrasonic washing); assembly and sterile processing of surgical trays during this period including robotic arms and instrumentation.

1.1. BACKGROUND. Sterile Processing Department (SPD) renovation project are still ongoing. The water at the facility is still not to standards for the cleaning and sterilizing of medical instruments.

1.2. QUALITY CONTROL (QC) PROGRAM.

1.2.1. QUALITY ASSURANCE (QA). The government will evaluate the Contractor’s performance by appointing a representative to monitor performance to ensure services are received.

1.2.1.1. Contractor should establish and monitor a QA/QC program to ensure that all processes and equipment are functioning as required.

1.2.1.2. Contractor will provide copies of requested QA/QC records to include maintenance records of equipment when requested or needed to facilitate inspection requirements for The Joint Commission.

1.2.2. Quality Assurance Personnel (QAP):

1.2.2.1. The QAP is the authorized government representative who will perform assessments of the Contractor’s performance.

1.2.2.2. The QAP or designee are the following: SPD Officer in Charge, the SPD Noncommissioned Officer in Charge and the SPD Supervisor.

1.2.2.3. The QAP or designee will inform the contract manager in person when discrepancies occur. The QAP or designee will make a notation of the discrepancy on their surveillance checklist with the date and time the discrepancy was noted and will request the contract manager (or authorized representative) to initial the entry on the checklist.

1.2.2.4. Any matter concerning a change to the scope, prices, terms, or conditions of this contract shall be referred to the Contracting Officer and not to the QAP.

1.2.3. The services to be performed by the Contractor during the period of this contract shall at all times and places be subject to review by the Contracting Officer or authorized representative.

1.2.4. The government shall notify the Contractor of any deficient instrument sets and the details related to the deficiency. The Contractor will review the information and report back to the government for the deficient sets.

1.3. PHYSICAL SECURITY. The Contractor shall safeguard all government property provided for Contractor use. At the close of each work period, Contractor facilities, government property, and materials shall be secured.

1.4. SAFETY REQUIREMENTS. In performing work under this contract, the contractor shall:

1.4.1. Conform to the safety requirements contained in the contract for all activities related to the accomplishment of the work.

1.4.2. Take such additional immediate precautions as the contracting officer may reasonably require for safety and mishap prevention purposes.

1.4.3. Provide protection to government property to prevent damage during the period of time the property is under the control or in possession of the Contractor.

1.4.4. Record and report promptly (within one hour) to the contracting officer or designated government representative all available facts relating to each instance of damage to government property.

1.4.5. In the event of an accident/mishap, take reasonable and prudent action to establish control of the accident/mishap scene, prevent further damage to persons or property, and preserve evidence until released by the accident/mishap investigative authority through the contracting officer.

1.4.6. If the government elects to investigate the accident/mishap, the Contractor shall cooperate fully and assist government personnel in the conduct of investigation until the investigation is completed.

1.5. COMPLAINTS. Complaints will be validated by the Contracting Officer’s Representative and be reported in writing to the Contracting Officer, Government designee and to the Contractor for action, if it constitutes a failure to perform, as determined by the Government. The contract provider shall have no more than two substantiated complaints per 12-month period.

PART 2

DEFINITIONS AND ACRONYMS

2.1. DEFINITIONS: The definitions set forth below are those unique to this contract. Definitions for technical terms or words that are included in this contract can be found in the technical documents referenced in the individual functional areas of the PWS. The definitions provided below are oriented to WBAMCs PWS. In many cases, definitions are specific by situation. The listing of definitions is not all-inclusive, but it has been derived from official publications (e.g., regulations and technical manuals) when available.

Acceptable Quality Level (AQL): The AQL is a designated value (percent) of defective outcomes/service that the Government indicates will be accepted using acceptable sampling techniques and procedures.

Alternate Contracting Officer’s Representative (ACOR): An alternate individual from the functional activity appointed by the Contracting Officer and delegated specific authority to monitor contract performance and to perform specific contract administration functions in the absence of the COR.

Contracting Officer (KO): An individual with the authority to enter into, administer, and/or terminate contracts and make related determinations and findings.

Contracting Officer's Representative (COR): An individual from the functional activity appointed by the Contracting Officer and delegated specific authority to monitor contract performance and to perform specific contract administration functions.

Defective Service: A unit of service, which contains one or more defects and does not conform to specified requirements.

Federal Acquisition Regulation (FAR): Provides uniform policies and procedures for acquisitions by executive agencies of the federal Government.

Government Furnished Property: All tangible property of Government furnished to Contractor.

Performance Standard: A measurable output or result associated with the performance-based description of a requirement found in the PWS.

Quality Control: Those actions taken by the Contractor to control the in-process performance of goods or services to ensure that contract quality standards are met.

Quality Assurance Surveillance Plan (QASP): An organized written document used by the Government for quality assurance surveillance.

2.2. ACRONYMS. For the purpose of the resultant contract, the acronyms listed below shall apply.

PART 3

GOVERNMENT-FURNISHED PROPERTY AND SERVICES

3.1. The government will provide an inventory list to the Contractor via email or fax or hard copy before delivery of the surgical trays/instrument sets.

3.2. When requested the government will provide all consumable components required for the assembly process, to include but not limited to filters, indicators, sharps protectors, paper pouches, and set locks/arrows. The government will send all consumable components with the WBAMC transportation driver to the Contractor.

3.3. The government will provide the Contractor with one electronic and/or hard copy of all count sheets for instrument sets to be reprocessed by the Contractor.

PART 4

CONTRACTOR-FURNISHED ITEMS AND SERVICES

4.1. With the exception of items specifically identified as Government furnished in Part 3.

4.2. The Contractor shall be TJC (The Joint Commission) accredited.

4.3 Unless otherwise stated, the Contractor will furnish all labor, supervision, equipment, materials, and supplies necessary to perform the services as required by the contract.

4.4. The Contractor shall obtain all necessary permits, give all notices, pay all license fees and applicable taxes, comply with municipal, State, and Federal laws, ordinances, rules, and regulations applicable to the business carried on under this contract.

4.5. CONTRACTOR OWNED PROPERTY:

4.5.1. Condition of Property: All property utilized on this contract shall be in an operable condition and shall meet all applicable Federal, State, Local, TJC, and requirements for its operation. Equipment shall also have complete and intact all design and safety features as if they were new excluding the appearance of fair wear and tear on the equipment.

4.5.2. Operation: All Contractor owned equipment shall be operated according to applicable Federal, State, Local, TJC and Installation laws and regulations as they apply to the equipment. This includes the requirement that Contractor personnel shall be adequately trained and possesses all necessary licenses, certification, or other required documents to operate the equipment.

PART 5

SPECIFIC TASKS

5.1. SPECIAL REQUIREMENTS.

5.1.1. The quantity of sets to be reprocessed has been identified as approximately 1500 sets/loads annually. This amount can be adjusted higher or lower.

5.1.2. WBAMC will deliver surgical trays to the Contractor daily at a time determined by both parties. Surgical trays that have not been decontaminated will be sprayed with enzymatic foam by WBAMC SPD staff prior to delivery to the Contractor.

5.1.2.1. WBAMC will provide, at the time of delivery of the surgical trays, a complete list of surgical trays, instruments, including count sheets, which are a part of the delivery and are to be sterilized by the Contractor.

5.1.2.2. WBAMC SPD staff will also provide manufacturer’s instructions, recommendations or guidelines for the decontamination and sterilization of the surgical trays delivered.

5.1.2.3. WBAMC staff will also scan all instrument trays with CensiTrac program to ensure chain of custody during entire process at the Contractor’s site.

5.1.3. The Contractor shall decontaminate and sterilize the surgical trays delivered by WBAMC in a manner consistent with the manufacturer’s instructions, recommendations and guidelines provided by WBAMC SPD staff.

5.1.4. WBAMC shall provide all transportation requirements.

5.1.5. The Contractor will complete the decontamination and sterilization of the WBAMC surgical trays with a 12–24-hour turn-around time.

5.1.6. The Contractor shall follow all regulatory requirements for medical instrument requirements.

5.1.7. The contractor shall maintain records of processes and provide copies of requested records to WBAMC when requested or as needed to facilitate inspection requirements for The Joint Commission.

5.2. General Services

5.2.1. The Contractor shall decontaminate all instrument sets utilizing the same cycle as validated per manufacturer’s guidance.

5.2.2. The Contractor shall inspect each instrument for cleanliness prior to assembly and sterilization.

5.2.3. WBAMC SPD staff shall assemble the instrument sets in accordance with the count sheet for completeness and in the correct order.

5.2.4. The Contractor shall place the provided indicators in each set, one on top of the instruments visible once the lid is removed, two in opposite corners of the bottom level, and one visible on the top of each additional level if applicable.

5.2.5. The Contractor shall use provided sharps protectors and paper pouches as indicated by the count sheets.

5.2.6. The Contractor shall include the folded count sheet inside each set, placed inside a paper pouch.

5.2.7. The Contractor shall inspect the provided filters for holes prior to placing them in the pan.

5.2.8. The Contractor shall use the provided pan locks/arrows to seal the set.

5.3. The Contractor shall sterilize all instrument sets utilizing the same cycle as validated manufacturer’s guidelines.

5.4. The Contractor shall follow all of their policies and procedures and quality testing and maintain records of the sterilization process.

5.5 The Contractor shall prepare all sets for transport back to WBAMC SPD.

5.6. The Contractor shall report any discovered violation of policy to the government along with the corrective action taken by the Contractor.

5.7. The Contractor shall ensure that only qualified, trained personnel will process the instrument sets for the government.

PART 6

OTHER TERMS, CONDITIONS, AND PROVISIONS

6.1. COMPLIANCE LANGUAGE/ EXCLUSION LIST SCREENING:

6.1.1. Compliance Language:

COMPLIANCE OBLIGATIONS. WBAMC represents that it read, understands, and shall abide by Tenet’s Standards of Conduct. The parties to this Agreement shall comply with Tenet’s Compliance Program and Tenet’s policies and procedures related to the Deficit Reduction Act of 2005, Anti-Kickback Statute and the Stark Law. Tenet’s Standards of Conduct, summary of Compliance Program, and policies and procedures, including a summary of the Federal False Claims Act and applicable state false claims laws (collectively “False Claims Laws”) with descriptions of penalties and whistleblower protections pertaining to such laws, are available at: Caution-http://www.tenethealth.com/about/ethics-compliance < Caution-http://www.tenethealth.com/about/ethicscompliance>. WBAMC shall require any employees providing services to Hospital to read the Standards of Conduct and information concerning Tenet’s Compliance Program and abide by same. Further, the parties to this Agreement certify that they shall not violate the Anti-Kickback Statute and Stark Law, and shall abide by the Deficit Reduction Act of 2005, as applicable, in providing services to Hospital. Hardcopies of any information shall be made available upon request. WBAMC and any employees, if applicable, shall complete any training required under Tenet’s Compliance Program.

6.1.2. EXCLUSION LISTS SCREENING.

WBAMC shall screen all of its current and prospective owners, legal entities, officers, directors, employees, contractors, and agents (“Screened Persons”) against (a) the United States Department of Health and Human Services/Office of Inspector General List of Excluded Individuals/Entities (available through the Internet at Caution-http://www.oig.hhs.gov < Caution-http://www.oig.hhs.gov/ > ), (b) the General Services Administration’s System for Award Management (available through the Internet at Caution-http://www.sam.gov < Caution-http://www.sam.gov > ), and (c) any applicable state healthcare exclusion list (collectively, the “Exclusion Lists”) to ensure that none of the Screened Persons are currently excluded, debarred, suspended, or otherwise ineligible to participate in Federal healthcare programs or in Federal procurement or non-procurement programs, or have been convicted of a criminal offense that falls within the ambit of 42 U.S.C. § 1320a-7(a), but have not yet been excluded, debarred, suspended, or otherwise declared ineligible (each, an “Ineligible Person”). If, at any time during the term of this Agreement any Screened Person becomes an Ineligible Person or proposed to be an Ineligible Person, WBAMC shall immediately notify Hospital of the same. Screened Persons shall not include any employee, contractor or agent who is not providing services under this Agreement.

6.2. 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. The following performance objectives and measures will be used to evaluate Contractor performance and compliance under the contract. This information will be used to prepare annual past performance evaluations.

Performance Objective

Quality Level

(AQL)

The Contractor shall follow all regulatory requirements for medical instrument requirements.

The contractor shall maintain records and/or processes and provide copies of requested records to the government when requested or as needed to facilitate inspections requirements for The Joint Commission.

Quality Assurance Inspections Contractor Quality Control (QC)

Customer Satisfaction Rate Two valid complaints within any twelve-month period may be considered grounds for immediate removal

Combating Trafficking in persons (awareness program) Zero tolerance regarding trafficking in persons policy

FAR 52.222-50

and FAR 22.1703

PART 7

ATTACHMENT AND TECHNICAL EXHIBIT LISTING

EXHIBIT A – PRICING INFORMATION