ATT 1- PWS - Sterile Processing Tech Services MEDVAMC.pdf

Performance Work Statement (PWS) Onsite Sterile Processing Technician Services

Michael E. DeBakey VA Medical Center (MEDVAMC)

Section 1: General Information

1.1. General: This is a non-personal services contract to provide Sterile Processing Technician Services for Michael E. DeBakey VA Medical Center (MEDVAMC), Operative Care Line. The Government shall not exercise any supervision or control over the contract service providers performing the services herein. Such contract services providers shall be accountable solely to the Contractor who, in turn is responsible to the Government.

1.2. Period of Performance (POP):

Base Year: TBD Option Year 1 TBD Option Year 2 TBD Option Year 3 TBD Option Year 4 TBD

1.3. Place of Performance: Michael E. DeBakey VA Medical Center 2002 Holcombe Boulevard Houston TX, 77030

1.4. Hours of Operation: MEDVAMC normal hours of duty are from Monday through Friday 7:00 a.m. to 4:30 p.m. Contractor technicians may be requested to perform outside of normal duty hours on Federal Holidays depending on workload and demand of MEDVAMC’s schedule.

1.5. Type of Contract: To be determined

Section 2: Description /Scope /Objective

2.1. Contractor must provide all labor, supervision and other items and services necessary to perform the work as defined in this PWS.

2.2. Contractor shall furnish a minimum of five (5) but not to exceed eight (8) qualified technicians to support the servicing of Orthopedic Instrumentation within the Sterile Processing Department at

MEDVAMC.

Section 3: Applicable Documents

3.1. The following laws, regulations, policies, and procedures in effect on date of contract issuance and all subsequent changes or updates apply:

FAR Federal Acquisition Regulation

VAAR Veterans Administration Acquisition Regulation

21 CFR Part 821 21 Code Federal Regulation Part 821-Tracking Requirements

CMS §482.41(c)(2) Center For Medicare and Medicaid Services Quality Standards

ANSI/AAMI EQ

56:1999/(R) 2008

Recommended Practice for a Medical Equipment Management Program

MVAHS 00-116-12 Use and Reprocessing of RME

SCA DOL Website Service Contract Act (SCA) Directory of Occupations (Fifth Edition) http://www.dol.gov/whd/contracts/sca.htm

Federal (includes VA), State, Local, Industry, Any Legal Doctrine/Permit/Code

Performance shall adhere to any and all legal, code, policy, procedure, standard and any applicable doctrine related to services IAW any and all:

Federal, State, Local, Industry or otherwise doctrine therein.

3.2. Glossary. Acronyms used in this PWS are listed below for easy reference:

AQL Acceptable Quality Level

Biomed Biomedical Service COR Contracting Officer’s Representative FAR Federal Acquisition Regulation

OR Operating Room OEM Original Equipment Manufacturer SPS Sterile Processing Services MEDVAMC Michael E. DeBakey VA Medical Center RME Reusable Medical Equipment

DOL Department of Labor VA Veterans Affairs HIPAA Health Insurance Portability and Accountability Act OSHA Occupational Safety and Health Administration CO Contracting Officer QASP Quality Assurance Surveillance Plan

Section 4: Performance Requirement

4.1. Contractor technicians shall coordinate the repairs and exchange of instrumentation.

4.1.1. MEDVAMC shall maintain financial responsibility with vendors other for payment of the repairs and exchange of equipment.

4.1.2. In the event MEDVAMC surgical volume changes, Contractor shall modify technical support resources as needed to adequately service the MEDVAMC without intervention required by MEDVAMC or change in the agreed upon per-case cost quoted unit prices.

4.2. Contractor technicians shall be knowledgeable and capable of utilizing computers to include: data entry, use of Microsoft Office, VistA, and be capable of learning and or knowledgeable of other applicable software as needed by MEDVAMC or recommended by Contractor (for approval by MEDVAMC) to perform the duties specified herein.

http://www.dol.gov/whd/contracts/sca.htm

4.2.1. Contractor technicians must obtain and maintain annual certification. Technicians must obtain their IAMCSMM CRCST Certification. In addition, Contractor technicians must successfully complete Stryker’s proprietary training held at Stryker’s National Training Center that is specific to Stryker’s products. A certificate of completion is received upon successfully completing the training program.

4.3. Contractor technicians shall organize and process equipment in the areas specified by MEDVAMC.

Technicians shall be able to lift up to 35 lbs. This includes palletizing of equipment and transporting items as needed by MEDVAMC.

4.4. Contractor technicians shall have excellent organizational skills: inventory organization of all equipment within rooms as indicated and required by MEDVAMC to maintain proper reporting and record keeping of all inventory.

4.5. Contractor technicians shall advise MEDVAMC with ways or methods to achieve and improve inventory control management and organization of all related equipment.

4.5.1. Contractor technicians shall analyze instrument usage versus on-hand inventory levels and provide MEDVAMC with recommendations on proper inventory level and surgical volume balance.

4.5.2. Contractor technicians shall implement practices that will result in a reduced repair frequency.

4.6. Contractor technicians shall maintain up to date training certification.

4.6.1 Contractor technicians will locally manage all training documents, competencies and Certificates.

4.6.2 Contractor technicians shall successfully complete the coursework and pass the Level 1 VA SPS Certification within the first 90 days of their hire date.

4.7. Contractor technician responsibilities include decontamination and assembly of Orthopedic and Power/Drills instrumentation sets.

4.7.1. Contractor technicians shall provide proactive proper care and handling, transport, storage, reprocessing and sterilization process for Orthopedic Instrumentation.

4.7.2. Contractor technicians shall provide 24/7 support, being on-site during peak times and offering on-call support for night and weekend coverage.

4.7.3. Contractor technicians will support Orthopedic surgical procedures and the reprocessing of Orthopedic surgical instrumentation sets listed below for the Sterile Processing Department within the MEDVAMC.

Stryker System 7 and System 8 Power Drill Sets Stryker Rem B Sets Stryker Sabo and Precision Instrumentation Sets

Stryker S2 and Sumex Drill Sets Stryker Small Joint and Formula Shavers Sets Stryker Pi Neuro and Dental Instrumentation Sets (Starting Day 30) Stryker Total Knee Instrumentation Sets (Starting Day 30) Stryker Total Hip Instrumentation Sets (Starting Day 30) Miscellaneous Joint/Loaner Sets (Starting Day 60) Zimmer Total Instrumentation Sets (Starting Day 60)

4.8. Contractor technicians are prohibited from performing or participating in direct patient contact, opening of sterile supplies, handling of any prescription or non-prescription medication for any purpose, advising staff or surgeons on the use of any medical devices in a medical procedure and sterilizing any instrument or device or validating the sterility of any instrument or device.

4.8.1. Contractor technicians are prohibited from initiating the sterilization process.

Section 5: Deliverables

5.1. Contractor technicians shall provide certification in the form of technical documentation, original invoice, or service documentation that the quality of updates and upgrades is sufficient to guarantee continued performance and operation of the system listed in this contract.

6.2.2. Contractor technicians will provide Procedural Summary each month

6.2.3. Contractor technicians will provide Trays Assembly analysis each month

6.2.4. Contractor technicians will provide Error reporting analysis each month

Section 6: Key Personnel Replacement and Substitution as applicable.

6.1. Requests for approval of substitutions shall be in writing and shall provide a detailed explanation of the circumstances necessitating the proposed substitutions. The request shall contain any other information requested or required by the Contracting Officer to approve or disapprove the request. The Contracting Officer or his/her authorized representative shall evaluate such requests and promptly notify the contractor in writing whether the proposed substitution is acceptable.

6.2. If the Contracting Officer determines that, (1) suitable and timely replacement of personnel who have been reassigned, terminated or have otherwise become unavailable for the contract work is not reasonably forthcoming, or (2) the resultant substitution would be so substantial as to impair the successful completion of the contract or the delivery order in accordance with the proposal accepted by MEDVAMC at time of contract award, the Contracting Officer may, (1) terminate the contract for default or for the convenience of MEDVAMC, as appropriate, or (2) at his discretion, if he finds Stryker at fault for the condition, equitably adjust the contract price downward to compensate MEDVAMC for any resultant delay, loss or damage.

Section 8: Management as applicable.

8.1. Contractor technicians shall be responsible for employing technically qualified Onsite technicians to perform the work specified in this PWS. Contractor shall maintain the personnel, organization and administrative control necessary to ensure that the work delivered meets the contract specifications and requirements.

8.2 Contractor Badges. Notwithstanding the requirement to wear a MEDVAMC furnished badge, Contractor technicians shall also wear a laminated identification badge at all times when performing services under this Contract, including when on MEDVAMC directed travel the badge will contain a personal picture and the Contractor technicians’ name. Badges shall be worn on the outer garment attached to the outer shirt or jacket pocket by a button or clip or worn around the neck secured by an appropriate identification card lanyard.

8.3. Contractor technicians attending meetings, answering MEDVAMC telephones, and working in other situations where their contractor status is not obvious to third parties are required to identify themselves as such to avoid creating an impression in the minds of members of the public or Congress that they are MEDVAMC officials. They must also ensure that all documents or reports produced by Contractor technicians are suitably marked as contractor products or that Contractor technician’s participation is appropriately disclosed.

8.4. Safety/Security Requirements. Contractor technicians shall comply with all applicable federal, state and local laws and ensure performance is secure while protecting material, equipment, and supplies from damage and loss. MEDVAMC security personnel shall have the express right to inspect for security violations at any time during the term of the contract.

8.5. All information generated in performance of this contract becomes property of MEDVAMC and must be surrendered upon request and/or completion of the contract. Contractor technicians must protect against the destruction and/or misplacement of all information produced under this contract, unless directed under local policy to destroy. This includes both hard and soft copies of data.

8.6. Contractor technicians shall not release any information (including photographs, files, public announcements, statements, denials, or confirmations) on any part of the subject matter of this contract or any phase of any program hereunder without the prior written approval of the COR.

8.7. Standards of conduct.

8.7.1. Conduct of Personnel. Contractor technicians shall conduct themselves in a professional manner (i.e. timeliness, communication; spoken and written etc.). The Contracting Officer may require the Contractor technicians to be removed from the job site if found working under this contract for reasons of suspected misconduct, a suspected security breach, or suspected to be under the influence of alcohol, drugs, or any other incapacitating agent.

Stryker Onsite Specialists shall be subject to dismissal from the premises upon determination by the Contracting Officer that such action is necessary in the interests of MEDVAMC. The hospital director or designated representative has the authority to bar individuals from MEDVAMC. The removal from the job site or dismissal from the premises shall not relieve Stryker of the requirement to provide sufficient personnel to perform the services as required by this performance work statement. MEDVAMC shall not reimburse Stryker for travel and other expenses associated with the removal of personnel.

8.7.2. Contractor technicians are not authorized to carry or possess personal weapons to include, but not limited to, firearms and knives with a blade length in excess of three inches, while assigned under this contract.

8.7.3. Working Attire and Appearance. Contractor technicians shall present a professional appearance commensurate with standards delineated for MEDVAMC civilian personnel acting in similar capacities.

8.7.4 MEDVAMC reserves the right to review Contractor technicians. Upon request, resumes shall be provided to the Contracting Officer prior to clearance approval, for review and acceptance by the COR. The intent is verification purpose and not for MEDVAMC to become the hiring authority.

Section 9: Travel - Not Applicable

Section 10: Non-Personal Service Statement

10.1. Contractor technicians performing services under this contract will be controlled, directed, and supervised at all times by management personnel of the contractor. Contractor’s management team will ensure that Contractor technicians properly comply with the performance work standards outlined in the PWS. Contractor technicians will perform their duties independent of, and without the supervision of, any MEDVAMC official. The tasks, duties, and responsibilities set forth in the contract may not be interpreted or implemented in any manner that results in any Contractor employee creating or modifying Federal policy, obligating the appropriated funds of the United States Government, overseeing the work of Federal employees, providing direct personal services to any Federal employee, or otherwise violating the prohibitions set forth in Parts 7.5 and 37.1 of the Federal Acquisition Regulation (FAR). MEDVAMC will control access to the facility and will perform the inspection and acceptance of the completed work.

Section 11: Personnel Qualifications

11.1. Contractor shall be responsible for employing technically qualified personnel to perform the work specified in this PWS. Contractor shall maintain the personnel, organization, and administrative control necessary to ensure that the work delivered meets the contract specifications and requirements.

MEDVAMC reserves the right, during the life of the resulting contract, to request work histories on any Contractor technicians for the purposes of verifying compliance with the above requirements. Onsite technicians assigned to, or utilized by, contractor in performance of work shall be fully capable of performing the requirements contained in the PWS in an efficient, reliable, and professional manner.

11.2. All work shall be completed by technicians in accordance with all applicable Federal, State, Local, and industry: standards, laws, policies, procedures, codes and any other applicable governing body for the proper performance of all equipment per manufactures specifications/calibrations. Stryker is to have proven access to applicable original equipment manufacturers (OEM) parts and manuals, which must be available on site to perform the services. All work is to be performed in accordance with the guidelines established by, State and local ordinances, with Manufacturer’s Manual and Quality Control Manual, and with all terms, conditions, provisions, schedules and Specifications provided herein.

11.2.1. Manufacturer trained and certified.

11.2.2. Have a strong knowledge of Medical Terminology, Surgical Procedures and the reprocessing of Reusable Medical Equipment.

11.2.3. Specialized Experience: Stryker shall provide evidence of factory training for each Onsite Specialists. Stryker Onsite Specialists shall provide technical guidance, education and customer support to the Operating Room, Sterile Processing Department and Biomedical personnel; ensure adherence to management, administrative, operational, and safety requirements of the DOL standard operating procedures. Stryker shall ensure that the equipment and instrumentation functions in conformance with manufacturer specifications.

11.3. Be authorized to work in the U.S.

End of PWS